Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time (NCT NCT01240863)
NCT ID: NCT01240863
Last Updated: 2017-06-05
Results Overview
The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
391 participants
Primary outcome timeframe
Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period
Results posted on
2017-06-05
Participant Flow
A total of 519 patients with osteoarthritis or low back pain were screened for enrollment into the study; of these, 391 patients at 71 centers in the US met entry criteria and were enrolled into the titration period of the study.
Of the 389 patients enrolled and treated during the titration period, 294 (75%) patients identified a successful dose and therefore completed the open-label titration period, and were randomly assigned to receive hydrocodone extended-release (ER) tablets (146 patients) or placebo (148 patients) in the double-blind treatment period.
Participant milestones
| Measure |
Hydrocodone ER (Open-Label Titration Period)
All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|
|
Open-label Titration Period
STARTED
|
391
|
0
|
0
|
|
Open-label Titration Period
Safety Analysis Set
|
389
|
0
|
0
|
|
Open-label Titration Period
COMPLETED
|
294
|
0
|
0
|
|
Open-label Titration Period
NOT COMPLETED
|
97
|
0
|
0
|
|
Double-blind Treatment Period (12 Weeks)
STARTED
|
0
|
148
|
146
|
|
Double-blind Treatment Period (12 Weeks)
Full Analysis and Safety Analysis Sets
|
0
|
147
|
146
|
|
Double-blind Treatment Period (12 Weeks)
COMPLETED
|
0
|
102
|
94
|
|
Double-blind Treatment Period (12 Weeks)
NOT COMPLETED
|
0
|
46
|
52
|
Reasons for withdrawal
| Measure |
Hydrocodone ER (Open-Label Titration Period)
All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|
|
Open-label Titration Period
Adverse Event
|
47
|
0
|
0
|
|
Open-label Titration Period
Lack of Efficacy
|
19
|
0
|
0
|
|
Open-label Titration Period
Withdrawal by Subject
|
9
|
0
|
0
|
|
Open-label Titration Period
Protocol Violation
|
7
|
0
|
0
|
|
Open-label Titration Period
Noncompliance to study drug admin
|
3
|
0
|
0
|
|
Open-label Titration Period
Noncompliance to study procedures
|
3
|
0
|
0
|
|
Open-label Titration Period
Dropped out prior to dosing
|
2
|
0
|
0
|
|
Open-label Titration Period
Other
|
7
|
0
|
0
|
|
Double-blind Treatment Period (12 Weeks)
Adverse Event
|
0
|
4
|
10
|
|
Double-blind Treatment Period (12 Weeks)
Lack of Efficacy
|
0
|
17
|
5
|
|
Double-blind Treatment Period (12 Weeks)
Withdrawal by Subject
|
0
|
3
|
5
|
|
Double-blind Treatment Period (12 Weeks)
Protocol Violation
|
0
|
9
|
14
|
|
Double-blind Treatment Period (12 Weeks)
Noncompliance to study drug admin
|
0
|
9
|
11
|
|
Double-blind Treatment Period (12 Weeks)
Noncompliance to study procedures
|
0
|
2
|
2
|
|
Double-blind Treatment Period (12 Weeks)
Other
|
0
|
1
|
5
|
|
Double-blind Treatment Period (12 Weeks)
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Includes participants with duration of opioid therapy data available.
Baseline characteristics by cohort
| Measure |
Placebo (Double-blind Treatment Period)
n=148 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.09 • n=148 Participants
|
53.6 years
STANDARD_DEVIATION 10.38 • n=146 Participants
|
53.1 years
STANDARD_DEVIATION 11.26 • n=294 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=148 Participants
|
87 Participants
n=146 Participants
|
175 Participants
n=294 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=148 Participants
|
59 Participants
n=146 Participants
|
119 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
White
|
105 Participants
n=148 Participants
|
115 Participants
n=146 Participants
|
220 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Black
|
41 Participants
n=148 Participants
|
28 Participants
n=146 Participants
|
69 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=148 Participants
|
3 Participants
n=146 Participants
|
5 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=148 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=148 Participants
|
9 Participants
n=146 Participants
|
12 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and non-Latino
|
144 Participants
n=148 Participants
|
137 Participants
n=146 Participants
|
281 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=148 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=294 Participants
|
|
Age group
<=65 years
|
133 Participants
n=148 Participants
|
126 Participants
n=146 Participants
|
259 Participants
n=294 Participants
|
|
Age group
>65 years
|
15 Participants
n=148 Participants
|
20 Participants
n=146 Participants
|
35 Participants
n=294 Participants
|
|
Body Mass Index
|
32.8 kg/m^2
STANDARD_DEVIATION 7.33 • n=148 Participants
|
33.0 kg/m^2
STANDARD_DEVIATION 8.16 • n=146 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 7.74 • n=294 Participants
|
|
Type of Pain
Low back pain
|
107 Participants
n=148 Participants
|
104 Participants
n=146 Participants
|
211 Participants
n=294 Participants
|
|
Type of Pain
Osteoarthritis
|
41 Participants
n=148 Participants
|
42 Participants
n=146 Participants
|
83 Participants
n=294 Participants
|
|
Duration since Diagnosis
|
12.5 years
STANDARD_DEVIATION 9.06 • n=148 Participants
|
12.1 years
STANDARD_DEVIATION 9.97 • n=146 Participants
|
12.3 years
STANDARD_DEVIATION 9.51 • n=294 Participants
|
|
Participants on Opioid Therapy
On opioid therapy
|
103 Participants
n=148 Participants
|
100 Participants
n=146 Participants
|
203 Participants
n=294 Participants
|
|
Participants on Opioid Therapy
Not on opioid therapy
|
45 Participants
n=148 Participants
|
46 Participants
n=146 Participants
|
91 Participants
n=294 Participants
|
|
Duration of Opioid Therapy
|
4.1 years
STANDARD_DEVIATION 4.90 • n=103 Participants • Includes participants with duration of opioid therapy data available.
|
3.9 years
STANDARD_DEVIATION 4.76 • n=100 Participants • Includes participants with duration of opioid therapy data available.
|
4.0 years
STANDARD_DEVIATION 4.82 • n=203 Participants • Includes participants with duration of opioid therapy data available.
|
PRIMARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment PeriodPopulation: Full analysis set (FAS). One placebo patient was withdrawn from the study prior to receiving drug in the Double-blind Treatment period and is not included in the FAS. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.
The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)
|
0.14 units on a scale
Standard Error 0.169
|
-0.22 units on a scale
Standard Error 0.176
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Week 12 of the double-blind treatment periodPopulation: Full analysis set
Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Total withdrawn from study period
|
31 percentage of participants
|
36 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Lack of efficacy
|
12 percentage of participants
|
3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Adverse event
|
3 percentage of participants
|
7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Consent withdrawn
|
2 percentage of participants
|
3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Lost to follow-up
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Protocol violation
|
6 percentage of participants
|
10 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Noncompliance to study procedures
|
1 percentage of participants
|
1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Noncompliance to study drug admin
|
6 percentage of participants
|
8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Other
|
1 percentage of participants
|
3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Week 12 of the double-blind treatment periodPopulation: Full analysis set
Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Kaplan-Meier Estimates for Time to Discontinuation From the Study
|
99 days
Interval 48.0 to 99.0
|
NA days
Interval 35.0 to
not estimable due to low rate of discontinuation
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
Week 1
|
14 Participants
|
13 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
Week 2
|
31 Participants
|
15 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
Week 4
|
32 Participants
|
17 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
Week 8
|
26 Participants
|
9 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
Week 12
|
24 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
Week 1
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
Week 2
|
16 Participants
|
9 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
Week 4
|
19 Participants
|
9 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
Week 8
|
20 Participants
|
6 Participants
|
—
|
—
|
|
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
Week 12
|
15 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Baseline
|
3.75 units on a scale
Standard Deviation 0.903
|
3.79 units on a scale
Standard Deviation 0.981
|
—
|
—
|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Week 1
|
3.73 units on a scale
Standard Deviation 1.319
|
3.67 units on a scale
Standard Deviation 1.291
|
—
|
—
|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Week 2
|
3.89 units on a scale
Standard Deviation 1.498
|
3.58 units on a scale
Standard Deviation 1.433
|
—
|
—
|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Week 4
|
3.78 units on a scale
Standard Deviation 1.702
|
3.48 units on a scale
Standard Deviation 1.447
|
—
|
—
|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Week 8
|
3.68 units on a scale
Standard Deviation 1.823
|
3.16 units on a scale
Standard Deviation 1.461
|
—
|
—
|
|
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
Week 12
|
3.61 units on a scale
Standard Deviation 1.783
|
3.30 units on a scale
Standard Deviation 1.638
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Baseline
|
4.75 units on a scale
Standard Deviation 1.369
|
4.85 units on a scale
Standard Deviation 1.265
|
—
|
—
|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Week 1
|
4.79 units on a scale
Standard Deviation 1.776
|
4.79 units on a scale
Standard Deviation 1.636
|
—
|
—
|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Week 2
|
5.02 units on a scale
Standard Deviation 1.951
|
4.65 units on a scale
Standard Deviation 1.781
|
—
|
—
|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Week 4
|
4.77 units on a scale
Standard Deviation 2.099
|
4.55 units on a scale
Standard Deviation 1.832
|
—
|
—
|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Week 8
|
4.57 units on a scale
Standard Deviation 2.228
|
4.18 units on a scale
Standard Deviation 1.892
|
—
|
—
|
|
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
Week 12
|
4.57 units on a scale
Standard Deviation 2.210
|
4.22 units on a scale
Standard Deviation 1.873
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 of the Double-blind Treatment PeriodPopulation: FAS of participants with assessments at the timeframe
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=110 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=105 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Slightly worsened
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Unchanged
|
31 Participants
|
23 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Slightly improved
|
33 Participants
|
38 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Much improved
|
31 Participants
|
29 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
General Activities: Very much improved
|
6 Participants
|
11 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Slightly worsened
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Unchanged
|
35 Participants
|
27 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Slightly improved
|
36 Participants
|
36 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Much improved
|
26 Participants
|
28 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Walking ability: Very much improved
|
5 Participants
|
10 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Slightly worsened
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Unchanged
|
36 Participants
|
24 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Slightly improved
|
32 Participants
|
39 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Much improved
|
29 Participants
|
29 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Daily living: Very much improved
|
7 Participants
|
8 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Slightly worsened
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Unchanged
|
72 Participants
|
60 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Slightly improved
|
13 Participants
|
18 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Much improved
|
16 Participants
|
18 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Relationships: Very much improved
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Slightly worsened
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Unchanged
|
48 Participants
|
39 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Slightly improved
|
26 Participants
|
26 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Much improved
|
19 Participants
|
28 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 4
Enjoyment: Very much improved
|
9 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 of the Double-blind Treatment PeriodPopulation: FAS of participants with assessments at the timeframe
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=98 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=91 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Slightly improved
|
12 Participants
|
19 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Much improved
|
16 Participants
|
17 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Slightly worsened
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Unchanged
|
38 Participants
|
38 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Slightly improved
|
19 Participants
|
20 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Much improved
|
27 Participants
|
25 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Very much improved
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Slightly worsened
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Unchanged
|
34 Participants
|
23 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Slightly improved
|
21 Participants
|
24 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Much improved
|
27 Participants
|
32 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
General Activities: Very much improved
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Much worsened
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Slightly worsened
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Unchanged
|
41 Participants
|
30 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Slightly improved
|
19 Participants
|
26 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Much improved
|
24 Participants
|
26 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Walking ability: Very much improved
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Very much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Slightly worsened
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Unchanged
|
38 Participants
|
25 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Slightly improved
|
22 Participants
|
35 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Much improved
|
24 Participants
|
21 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Daily living: Very much improved
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Slightly worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Unchanged
|
68 Participants
|
49 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Relationships: Very much improved
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 8
Enjoyment: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 of the Double-blind Treatment PeriodPopulation: FAS of participants with assessments at the timeframe
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=92 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=86 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Much improved
|
18 Participants
|
27 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Very much improved
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Much worsened
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Slightly worsened
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Unchanged
|
29 Participants
|
20 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Slightly improved
|
29 Participants
|
27 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Much improved
|
19 Participants
|
27 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
General Activities: Very much improved
|
11 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Slightly worsened
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Unchanged
|
38 Participants
|
24 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Walking ability: Slightly improved
|
26 Participants
|
24 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Much worsened
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Slightly worsened
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Unchanged
|
30 Participants
|
28 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Slightly improved
|
26 Participants
|
22 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Much improved
|
20 Participants
|
26 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Daily living: Very much improved
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Slightly worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Unchanged
|
59 Participants
|
47 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Slightly improved
|
13 Participants
|
18 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Much improved
|
15 Participants
|
14 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Relationships: Very much improved
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Slightly worsened
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Unchanged
|
42 Participants
|
31 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Slightly improved
|
16 Participants
|
23 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Much improved
|
21 Participants
|
21 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Week 12
Enjoyment: Very much improved
|
8 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint of the Double-blind Treatment Period (up to week 12)Population: FAS of participants with assessments at the timeframe
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. Endpoint values are the last observed postbaseline data.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=131 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=132 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Much worsened
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Slightly worsened
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Unchanged
|
46 Participants
|
38 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Slightly improved
|
36 Participants
|
37 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Much improved
|
24 Participants
|
40 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
General Activities: Very much improved
|
11 Participants
|
8 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Very much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Much worsened
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Slightly worsened
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Unchanged
|
59 Participants
|
45 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Slightly improved
|
34 Participants
|
32 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Much improved
|
21 Participants
|
19 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Walking ability: Very much improved
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Much worsened
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Slightly worsened
|
10 Participants
|
3 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Unchanged
|
49 Participants
|
46 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Slightly improved
|
33 Participants
|
33 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Much improved
|
24 Participants
|
36 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Daily living: Very much improved
|
10 Participants
|
8 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Much worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Slightly worsened
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Unchanged
|
90 Participants
|
78 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Slightly improved
|
15 Participants
|
26 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Much improved
|
18 Participants
|
15 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Relationships: Very much improved
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Much worsened
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Unchanged
|
66 Participants
|
57 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Much improved
|
25 Participants
|
27 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Very much improved
|
8 Participants
|
7 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Slightly worsened
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Clinician Assessment of Patient Function (CAPF) at Endpoint
Enjoyment: Slightly improved
|
20 Participants
|
31 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 of the Double-blind Treatment PeriodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Much worsened
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Slightly worsened
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Unchanged
|
34 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Slightly improved
|
13 Participants
|
17 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Much improved
|
12 Participants
|
19 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Go to Work: Very much improved
|
6 Participants
|
8 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Much worsened
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Slightly worsened
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Unchanged
|
33 Participants
|
20 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Slightly improved
|
32 Participants
|
38 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Much improved
|
22 Participants
|
31 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Perform Work: Very much improved
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Very much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Slightly worsened
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Unchanged
|
37 Participants
|
24 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Slightly improved
|
32 Participants
|
34 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Much improved
|
27 Participants
|
30 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Walk: Very much improved
|
6 Participants
|
10 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Very much worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Much worsened
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Slightly worsened
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Unchanged
|
46 Participants
|
31 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Slightly improved
|
30 Participants
|
39 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Much improved
|
18 Participants
|
20 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Exercise: Very much improved
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Slightly worsened
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Unchanged
|
52 Participants
|
37 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Slightly improved
|
26 Participants
|
28 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Much improved
|
14 Participants
|
22 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Social events: Very much improved
|
8 Participants
|
13 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Very much worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Much worsened
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Slightly worsened
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Unchanged
|
66 Participants
|
64 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Slightly improved
|
18 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Much improved
|
5 Participants
|
15 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Sex: Very much improved
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Slightly worsened
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Unchanged
|
41 Participants
|
34 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Slightly improved
|
28 Participants
|
27 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Much improved
|
20 Participants
|
28 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 4
Enjoy life: Very much improved
|
11 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 of the Double-blind Treatment PeriodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Very much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Unchanged
|
31 Participants
|
29 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Unchanged
|
38 Participants
|
22 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Slightly improved
|
22 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Much improved
|
17 Participants
|
33 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Much worsened
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Slightly worsened
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Unchanged
|
40 Participants
|
22 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Much improved
|
17 Participants
|
27 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Very much improved
|
9 Participants
|
10 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Very much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Unchanged
|
42 Participants
|
28 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Slightly improved
|
23 Participants
|
28 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Much improved
|
16 Participants
|
21 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Very much improved
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Much worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Unchanged
|
48 Participants
|
42 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Very much improved
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Slightly improved
|
9 Participants
|
12 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Much improved
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Very much improved
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Slightly worsened
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Unchanged
|
41 Participants
|
34 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Slightly improved
|
24 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Very much worsened
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Much worsened
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Slightly worsened
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Slightly improved
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Much improved
|
14 Participants
|
18 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Go to Work: Very much improved
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Much worsened
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Slightly worsened
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Perform Work: Very much improved
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Walk: Slightly improved
|
23 Participants
|
27 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Much worsened
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Exercise: Slightly worsened
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Slightly worsened
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Slightly improved
|
18 Participants
|
19 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Social events: Much improved
|
18 Participants
|
19 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Slightly worsened
|
3 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Sex: Unchanged
|
74 Participants
|
52 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Much improved
|
23 Participants
|
23 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 8
Enjoy life: Very much improved
|
3 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 of the Double-blind Treatment PeriodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Unchanged
|
27 Participants
|
19 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Slightly improved
|
7 Participants
|
18 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Very much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Very much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Much worsened
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Slightly worsened
|
10 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Much improved
|
23 Participants
|
23 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Very much improved
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Very much worsened
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Much worsened
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Slightly worsened
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Unchanged
|
34 Participants
|
30 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Slightly improved
|
23 Participants
|
26 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Much improved
|
15 Participants
|
14 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Exercise: Very much improved
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Much worsened
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Slightly worsened
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Unchanged
|
45 Participants
|
29 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Slightly improved
|
16 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Much improved
|
17 Participants
|
16 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Social events: Very much improved
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Very much worsened
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Much worsened
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Slightly worsened
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Unchanged
|
64 Participants
|
46 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Slightly improved
|
7 Participants
|
11 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Much improved
|
6 Participants
|
12 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Sex: Very much improved
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Very much worsened
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Much worsened
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Slightly worsened
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Unchanged
|
36 Participants
|
27 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Slightly improved
|
21 Participants
|
18 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Much improved
|
18 Participants
|
24 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Enjoy life: Very much improved
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Slightly improved
|
26 Participants
|
26 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Much improved
|
21 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Much worsened
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Slightly worsened
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Much improved
|
13 Participants
|
17 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Go to Work: Very much improved
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Much worsened
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Slightly worsened
|
10 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Unchanged
|
26 Participants
|
20 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Perform Work: Very much improved
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Unchanged
|
29 Participants
|
20 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Week 12
Walk: Slightly improved
|
20 Participants
|
27 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint of the Double-blind Treatment Period (up to week 12)Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life Endpoint values are the last observed postbaseline data.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Very much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Very much worsened
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Much worsened
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Slightly worsened
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Unchanged
|
47 Participants
|
39 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Slightly improved
|
11 Participants
|
26 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Much improved
|
21 Participants
|
26 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Go to Work: Very much improved
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Very much worsened
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Much worsened
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Slightly worsened
|
17 Participants
|
12 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Unchanged
|
43 Participants
|
34 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Slightly improved
|
31 Participants
|
39 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Much improved
|
27 Participants
|
34 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Perform Work: Very much improved
|
8 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Much worsened
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Slightly worsened
|
13 Participants
|
10 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Unchanged
|
47 Participants
|
36 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Slightly improved
|
28 Participants
|
40 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Much improved
|
28 Participants
|
32 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Walk: Very much improved
|
7 Participants
|
10 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Very much worsened
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Much worsened
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Slightly worsened
|
13 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Unchanged
|
52 Participants
|
51 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Slightly improved
|
30 Participants
|
30 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Much improved
|
19 Participants
|
24 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Exercise: Very much improved
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Very much worsened
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Much worsened
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Slightly worsened
|
10 Participants
|
12 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Unchanged
|
67 Participants
|
51 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Slightly improved
|
23 Participants
|
30 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Much improved
|
21 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Social events: Very much improved
|
6 Participants
|
10 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Very much worsened
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Much worsened
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Slightly worsened
|
10 Participants
|
12 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Unchanged
|
88 Participants
|
76 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Slightly improved
|
12 Participants
|
13 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Much improved
|
8 Participants
|
18 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Sex: Very much improved
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Very much worsened
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Much worsened
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Slightly worsened
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Unchanged
|
59 Participants
|
45 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Slightly improved
|
27 Participants
|
25 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Much improved
|
21 Participants
|
35 Participants
|
—
|
—
|
|
Patient Assessment of Function (PAF) at Endpoint
Enjoy life: Very much improved
|
9 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The CGI-S is a clinician-rated scale that assesses the severity of the patient's pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories: * 1 normal-shows no sign of illness, * 2 borderline ill, * 3 mildly (slightly) ill, * 4 moderately ill, * 5 markedly ill, * 6 severely ill, and * 7 among the most extremely ill (Guy 1976). The clinician assesses the severity of the patient's condition, based on the clinician's total clinical experience with patients with this condition, in response to treatment. Endpoint values are the last observed postbaseline data.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Baseline
|
3.0 units on a scale
Standard Deviation 1.19
|
2.8 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Week 1
|
2.9 units on a scale
Standard Deviation 1.16
|
2.9 units on a scale
Standard Deviation 1.10
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Week 2
|
2.9 units on a scale
Standard Deviation 1.20
|
2.8 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Week 4
|
2.9 units on a scale
Standard Deviation 1.26
|
2.7 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Week 8
|
2.8 units on a scale
Standard Deviation 1.21
|
2.7 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Week 12
|
2.8 units on a scale
Standard Deviation 1.19
|
2.7 units on a scale
Standard Deviation 1.08
|
—
|
—
|
|
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
Endpoint
|
2.9 units on a scale
Standard Deviation 1.18
|
2.8 units on a scale
Standard Deviation 1.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
MCS - Baseline
|
52.8 units on a scale
Standard Deviation 9.99
|
52.8 units on a scale
Standard Deviation 10.47
|
—
|
—
|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
PCS - Baseline
|
35.5 units on a scale
Standard Deviation 8.96
|
35.8 units on a scale
Standard Deviation 9.28
|
—
|
—
|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
PCS - Week 12
|
36.9 units on a scale
Standard Deviation 10.04
|
37.6 units on a scale
Standard Deviation 9.04
|
—
|
—
|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
PCS - Endpoint
|
35.9 units on a scale
Standard Deviation 10.13
|
36.9 units on a scale
Standard Deviation 9.16
|
—
|
—
|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
MCS - Week 12
|
54.7 units on a scale
Standard Deviation 9.71
|
53.6 units on a scale
Standard Deviation 8.06
|
—
|
—
|
|
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
MCS - Endpoint
|
54.0 units on a scale
Standard Deviation 10.27
|
52.6 units on a scale
Standard Deviation 9.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 \[does not interfere\] to 10 \[completely interferes\]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Endpoint
|
3.5 units on a scale
Standard Deviation 2.45
|
3.3 units on a scale
Standard Deviation 2.28
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Baseline
|
2.9 units on a scale
Standard Deviation 2.09
|
2.8 units on a scale
Standard Deviation 2.05
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Week 1
|
3.0 units on a scale
Standard Deviation 2.23
|
3.1 units on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Week 2
|
2.9 units on a scale
Standard Deviation 2.25
|
2.7 units on a scale
Standard Deviation 2.19
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Week 4
|
2.9 units on a scale
Standard Deviation 2.39
|
2.8 units on a scale
Standard Deviation 2.06
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Week 8
|
2.9 units on a scale
Standard Deviation 2.37
|
2.9 units on a scale
Standard Deviation 2.23
|
—
|
—
|
|
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
Week 12
|
3.0 units on a scale
Standard Deviation 2.31
|
3.3 units on a scale
Standard Deviation 2.30
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment periodPopulation: Safety analysis set (Open-Label Titration) and FAS (Double-Blind Treatment)
An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=189 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=200 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Participants With Adverse Events
Severe adverse event
|
9 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
|
Participants With Adverse Events
Treatment-related adverse event
|
90 Participants
|
72 Participants
|
28 Participants
|
48 Participants
|
|
Participants With Adverse Events
Any adverse event
|
111 Participants
|
116 Participants
|
91 Participants
|
93 Participants
|
|
Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Adverse Events
Serious adverse event
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Participants With Adverse Events
Withdrawals from treatment due to AE
|
33 Participants
|
15 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 128 in Double-Blind Treatment periodPopulation: FAS
Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Pulse - high
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Systolic blood pressure - high
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Diastolic blood pressure - low
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
At least one clinically significant vital sign
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Pulse - low
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Systolic blood pressure - low
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Diastolic blood pressure - high
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 128 in Double-Blind Treatment periodPopulation: Full analysis set including participants with laboratory assessments
Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Uric acid: M\>=625, F\>=506 μmol/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 % * Urinalysis: blood (hemoglobin) and total protein: \>=2 unit increase from baseline
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Uric acid
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Blood urea nitrogen
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Hemoglobin
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Hematocrit
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Urine blood
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Urine total protein
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Week 2
|
5.4 units on a scale
Standard Deviation 5.59
|
4.4 units on a scale
Standard Deviation 5.10
|
—
|
—
|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Week 1
|
5.9 units on a scale
Standard Deviation 5.39
|
6.1 units on a scale
Standard Deviation 5.93
|
—
|
—
|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Week 4
|
5.5 units on a scale
Standard Deviation 6.16
|
5.3 units on a scale
Standard Deviation 5.37
|
—
|
—
|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Week 8
|
3.4 units on a scale
Standard Deviation 4.68
|
3.2 units on a scale
Standard Deviation 4.23
|
—
|
—
|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Week 12
|
3.2 units on a scale
Standard Deviation 4.73
|
3.6 units on a scale
Standard Deviation 5.29
|
—
|
—
|
|
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
Endpoint
|
3.6 units on a scale
Standard Deviation 4.96
|
4.3 units on a scale
Standard Deviation 6.30
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The COWS was a clinician rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: * 0 to 4=normal * 5 to 12=mild * 13 to 24=moderate * 25 to 36=moderately severe * \>36=severe
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Baseline
|
0.5 units on a scale
Standard Deviation 0.90
|
0.5 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Week 1
|
0.8 units on a scale
Standard Deviation 1.51
|
0.7 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Week 2
|
0.7 units on a scale
Standard Deviation 1.33
|
0.5 units on a scale
Standard Deviation 0.92
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Week 4
|
0.8 units on a scale
Standard Deviation 1.58
|
0.6 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Week 8
|
0.7 units on a scale
Standard Deviation 1.34
|
0.6 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Week 12
|
0.5 units on a scale
Standard Deviation 0.92
|
0.8 units on a scale
Standard Deviation 1.76
|
—
|
—
|
|
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
Endpoint
|
0.7 units on a scale
Standard Deviation 1.13
|
1.1 units on a scale
Standard Deviation 2.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 12
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.38
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Endpoint
|
0.3 units on a scale
Standard Deviation 0.75
|
0.3 units on a scale
Standard Deviation 0.73
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Baseline Open-Label Titration
|
0.3 units on a scale
Standard Deviation 0.65
|
0.3 units on a scale
Standard Deviation 0.70
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Baseline Double-blind Treatment
|
0.1 units on a scale
Standard Deviation 0.39
|
0.2 units on a scale
Standard Deviation 0.43
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 1
|
0.2 units on a scale
Standard Deviation 0.47
|
0.2 units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 4
|
0.1 units on a scale
Standard Deviation 0.40
|
0.3 units on a scale
Standard Deviation 0.70
|
—
|
—
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 8
|
0.1 units on a scale
Standard Deviation 0.36
|
0.2 units on a scale
Standard Deviation 0.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment periodPopulation: Full analysis set. Participants contributing to each time point are included in the number analyzed.
The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior. The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=147 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Baseline Open-Label Titration
|
3.7 units on a scale
Standard Deviation 4.10
|
4.2 units on a scale
Standard Deviation 4.14
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Baseline Double-blind Treatment
|
3.7 units on a scale
Standard Deviation 4.12
|
3.9 units on a scale
Standard Deviation 4.29
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 1
|
2.9 units on a scale
Standard Deviation 3.70
|
3.1 units on a scale
Standard Deviation 3.10
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 4
|
2.4 units on a scale
Standard Deviation 3.10
|
2.8 units on a scale
Standard Deviation 3.31
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 8
|
2.5 units on a scale
Standard Deviation 3.51
|
2.2 units on a scale
Standard Deviation 2.87
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Week 12
|
2.8 units on a scale
Standard Deviation 3.51
|
3.0 units on a scale
Standard Deviation 3.53
|
—
|
—
|
|
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
Endpoint
|
3.0 units on a scale
Standard Deviation 3.67
|
3.3 units on a scale
Standard Deviation 3.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment periodPopulation: FAS of participants contributing baseline and endpoint data.
A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=146 Participants
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=142 Participants
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
Placebo (Double-blind Treatment Period)
Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
PR interval
|
-1.8 msec
Standard Deviation 16.27
|
-2.4 msec
Standard Deviation 29.30
|
—
|
—
|
|
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
QRS interval
|
-0.1 msec
Standard Deviation 15.96
|
0.6 msec
Standard Deviation 10.43
|
—
|
—
|
|
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
QT interval
|
-3.1 msec
Standard Deviation 27.08
|
2.2 msec
Standard Deviation 28.28
|
—
|
—
|
|
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
QTc interval (Bazett)
|
-1.0 msec
Standard Deviation 20.34
|
4.2 msec
Standard Deviation 22.74
|
—
|
—
|
|
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
QTc interval (Fridericia)
|
-2.5 msec
Standard Deviation 21.10
|
2.9 msec
Standard Deviation 21.70
|
—
|
—
|
Adverse Events
Hydrocodone ER (Open-Label Titration Period)
Serious events: 2 serious events
Other events: 167 other events
Deaths: 0 deaths
Placebo (Double-blind Treatment Period)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Hydrocodone ER (Double-blind Treatment Period)
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydrocodone ER (Open-Label Titration Period)
n=389 participants at risk
All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
|
Placebo (Double-blind Treatment Period)
n=147 participants at risk
Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 participants at risk
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/146 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/146 • Number of events 2 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
General disorders
Hernia obstructive
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/146 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/146 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/146 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 2 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/146 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/389 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/146 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Renal and urinary disorders
Renal failure acute
|
0.26%
1/389 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/146 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/389 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/147 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.00%
0/146 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
Other adverse events
| Measure |
Hydrocodone ER (Open-Label Titration Period)
n=389 participants at risk
All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
|
Placebo (Double-blind Treatment Period)
n=147 participants at risk
Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
|
Hydrocodone ER (Double-blind Treatment Period)
n=146 participants at risk
Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.1%
55/389 • Number of events 61 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
4.8%
7/147 • Number of events 8 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
13.0%
19/146 • Number of events 19 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Gastrointestinal disorders
Nausea
|
18.0%
70/389 • Number of events 75 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
6.1%
9/147 • Number of events 11 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
13.0%
19/146 • Number of events 20 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
25/389 • Number of events 26 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
3.4%
5/147 • Number of events 6 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
6.2%
9/146 • Number of events 9 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Nervous system disorders
Dizziness
|
5.7%
22/389 • Number of events 23 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
2.1%
3/146 • Number of events 3 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Nervous system disorders
Headache
|
11.1%
43/389 • Number of events 50 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
5.4%
8/147 • Number of events 8 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
6.8%
10/146 • Number of events 13 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Nervous system disorders
Somnolence
|
11.6%
45/389 • Number of events 51 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
2.1%
3/146 • Number of events 3 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
20/389 • Number of events 23 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
0.68%
1/147 • Number of events 1 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
2.1%
3/146 • Number of events 4 • Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER