Trial Outcomes & Findings for Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets (NCT NCT01922739)
NCT ID: NCT01922739
Last Updated: 2021-11-09
Results Overview
A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period \[or early termination\]). A qualified physician at the study center was responsible for providing interpretation of the ECG. Endpoint refers to the last observation carried forward.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)
Results posted on
2021-11-09
Participant Flow
A total of 183 patients with moderate to severe chronic low back pain completed Study 3103 and were screened and eligible for enrollment into this study. One patient chose not to participate prior to enrollment.
Of the 182 participants who enrolled into Study 3104, 26 participants enrolled under the original protocol and 156 participants enrolled under the amended protocol.
Participant milestones
| Measure |
Hydrocodone ER
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
|
|---|---|
|
Titration/Adjustment Period
STARTED
|
182
|
|
Titration/Adjustment Period
Safety Analysis Set
|
182
|
|
Titration/Adjustment Period
COMPLETED
|
170
|
|
Titration/Adjustment Period
NOT COMPLETED
|
12
|
|
Open-label Treatment Period
STARTED
|
170
|
|
Open-label Treatment Period
Treatment SAS and FAS
|
170
|
|
Open-label Treatment Period
COMPLETED
|
136
|
|
Open-label Treatment Period
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Hydrocodone ER
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
|
|---|---|
|
Titration/Adjustment Period
Adverse Event
|
3
|
|
Titration/Adjustment Period
Withdrawal by Subject
|
5
|
|
Titration/Adjustment Period
Lost to Follow-up
|
1
|
|
Titration/Adjustment Period
Lack of Efficacy
|
3
|
|
Open-label Treatment Period
Adverse Event
|
6
|
|
Open-label Treatment Period
Withdrawal by Subject
|
14
|
|
Open-label Treatment Period
Noncompliance to study medication
|
3
|
|
Open-label Treatment Period
Protocol Violation
|
5
|
|
Open-label Treatment Period
Pregnancy
|
1
|
|
Open-label Treatment Period
Noncompliance to study procedures
|
1
|
|
Open-label Treatment Period
Lost to Follow-up
|
2
|
|
Open-label Treatment Period
Physician Decision
|
1
|
|
Open-label Treatment Period
Sponsor request - investigator leaving
|
1
|
Baseline Characteristics
for some individual participants, the data values were missing
Baseline characteristics by cohort
| Measure |
Hydrocodone ER - Opioid Naive
n=109 Participants
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
|
Hydrocodone ER - Opioid Experienced
n=73 Participants
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 13.30 • n=109 Participants
|
55.8 years
STANDARD_DEVIATION 12.37 • n=73 Participants
|
52.3 years
STANDARD_DEVIATION 13.22 • n=182 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=109 Participants
|
40 Participants
n=73 Participants
|
100 Participants
n=182 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=109 Participants
|
33 Participants
n=73 Participants
|
82 Participants
n=182 Participants
|
|
Age Group
<=65 years
|
94 Participants
n=109 Participants
|
53 Participants
n=73 Participants
|
147 Participants
n=182 Participants
|
|
Age Group
>65 years
|
15 Participants
n=109 Participants
|
20 Participants
n=73 Participants
|
35 Participants
n=182 Participants
|
|
Race
White
|
69 Participants
n=109 Participants
|
58 Participants
n=73 Participants
|
127 Participants
n=182 Participants
|
|
Race
Black
|
27 Participants
n=109 Participants
|
12 Participants
n=73 Participants
|
39 Participants
n=182 Participants
|
|
Race
Asian
|
9 Participants
n=109 Participants
|
1 Participants
n=73 Participants
|
10 Participants
n=182 Participants
|
|
Race
American Indian or Alaskan Native
|
2 Participants
n=109 Participants
|
1 Participants
n=73 Participants
|
3 Participants
n=182 Participants
|
|
Race
Pacific Islander
|
1 Participants
n=109 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=182 Participants
|
|
Race
Other
|
1 Participants
n=109 Participants
|
1 Participants
n=73 Participants
|
2 Participants
n=182 Participants
|
|
Ethnicity
Hispanic or Latino
|
24 Participants
n=109 Participants
|
4 Participants
n=73 Participants
|
28 Participants
n=182 Participants
|
|
Ethnicity
Non-Hispanic and non-Latino
|
85 Participants
n=109 Participants
|
69 Participants
n=73 Participants
|
154 Participants
n=182 Participants
|
|
Weight
|
94.2 kg
STANDARD_DEVIATION 24.56 • n=109 Participants
|
94.2 kg
STANDARD_DEVIATION 25.07 • n=73 Participants
|
94.2 kg
STANDARD_DEVIATION 24.69 • n=182 Participants
|
|
Height
|
169.3 cm
STANDARD_DEVIATION 10.77 • n=109 Participants
|
172.1 cm
STANDARD_DEVIATION 11.18 • n=73 Participants
|
170.4 cm
STANDARD_DEVIATION 10.99 • n=182 Participants
|
|
Body Mass Index
|
32.9 kg/m^2
STANDARD_DEVIATION 8.41 • n=109 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 8.27 • n=73 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 8.35 • n=182 Participants
|
|
Duration Since Diagnosis of Chronic Low Back Pain
|
10.7 years
STANDARD_DEVIATION 10.33 • n=109 Participants
|
12.8 years
STANDARD_DEVIATION 11.43 • n=73 Participants
|
11.6 years
STANDARD_DEVIATION 10.80 • n=182 Participants
|
|
Duration on Opioid Therapy
|
2.1 years
STANDARD_DEVIATION 4.72 • n=109 Participants
|
4.8 years
STANDARD_DEVIATION 4.06 • n=73 Participants
|
3.2 years
STANDARD_DEVIATION 4.65 • n=182 Participants
|
|
Worst Pain Intensity (WPI) Score
|
3.7 units on a scale
STANDARD_DEVIATION 1.71 • n=106 Participants • for some individual participants, the data values were missing
|
4.6 units on a scale
STANDARD_DEVIATION 2.13 • n=64 Participants • for some individual participants, the data values were missing
|
4.1 units on a scale
STANDARD_DEVIATION 1.92 • n=170 Participants • for some individual participants, the data values were missing
|
|
Average Pain Intensity (API)
|
2.6 units on a scale
STANDARD_DEVIATION 1.41 • n=106 Participants • for some individual participants, the data value was missing
|
3.0 units on a scale
STANDARD_DEVIATION 1.78 • n=64 Participants • for some individual participants, the data value was missing
|
2.7 units on a scale
STANDARD_DEVIATION 1.57 • n=170 Participants • for some individual participants, the data value was missing
|
PRIMARY outcome
Timeframe: Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)Population: Safety Analysis Set for the Titration/Adjustment period; Post-Titration/Post-Adjustment Safety Analysis Set for the Open-Label Treatment Period
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 Titration Period
n=10 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
n=16 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
n=68 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
n=88 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
n=170 Participants
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Participants With Adverse Events
Severe AE
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
|
Participants With Adverse Events
Serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
|
Participants With Adverse Events
Withdrawals from treatment due to AE
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Participants With Adverse Events
Any AE
|
4 Participants
|
2 Participants
|
34 Participants
|
25 Participants
|
88 Participants
|
|
Participants With Adverse Events
Treatment-related AE
|
3 Participants
|
2 Participants
|
21 Participants
|
10 Participants
|
26 Participants
|
|
Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)Population: The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline result for each test are counted as part of the number of participants analyzed for that test.
Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Creatinine: \>=177 μmol/L * Uric acid: M\>=625, F\>=506 μmol/L * Aspartate aminotransferase (AST): \>=3\* upper limit of normal (ULN) * Alkaline phosphatase: \>=3\* upper limit of normal (ULN) * Gamma-glutamyl transpeptidase (GGT): \>=3\* upper limit of normal (ULN) * Serum white blood cells: \>=20 \* 10\^9/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 L/L * Eosinophils: \>=10.0 % * Platelets: \<=75 \* 10\^9/L * Absolute neutrophils: \<=1.0 \* 10\^9/L * Urinalysis: Glucose, Ketones, and Total Protein: \>=2 unit increase from baseline
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=170 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Blood urea nitrogen
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Creatinine
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Uric acid
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
AST
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Alkaline phosphatase
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
GGT
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Serum white blood cells
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hemoglobin
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hematocrit
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Eosinophils
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Platelets
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Absolute neutrophils
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Urine glucose
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Urine ketones
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Laboratory Values
Urine total protein
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)Population: The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline vital sign result are counted as part of the number of participants analyzed.
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 Titration Period
n=178 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Pulse - high
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Pulse - low
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Systolic blood pressure - high
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Systolic blood pressure - low
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Diastolic blood pressure - high
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Diastolic blood pressure - low
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)Population: Post-Titration Safety Analysis Set
The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=170 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Participants With Shifts From Normal to Abnormal in Physical Examination Findings
Normal at baseline - Abnormal at Endpoint
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Participants With Shifts From Normal to Abnormal in Physical Examination Findings
Abnormal findings reported as adverse events
|
7 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)Population: Post-Titration Safety Analysis Set. Includes participants who have both baseline and endpoint data.
A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period \[or early termination\]). A qualified physician at the study center was responsible for providing interpretation of the ECG. Endpoint refers to the last observation carried forward.
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=97 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
n=60 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
n=157 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
Baseline normal - Endpoint normal
|
26 Participants
|
19 Participants
|
45 Participants
|
—
|
—
|
|
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
Baseline normal - Endpoint abnormal
|
18 Participants
|
11 Participants
|
29 Participants
|
—
|
—
|
|
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
Baseline abnormal - Endpoint normal
|
11 Participants
|
8 Participants
|
19 Participants
|
—
|
—
|
|
Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings
Baseline abnormal - Endpoint abnormal
|
42 Participants
|
22 Participants
|
64 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)Population: Safety Analysis Set
Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in \[Konrad-Martin et al 2005\]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to "no response" at 3 consecutive test frequencies.
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=109 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
n=73 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
n=182 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results
|
11 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment PeriodPopulation: Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.
The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=106 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
n=64 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
n=170 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 2
|
0.0 units on a scale
Standard Deviation 1.23
|
0.2 units on a scale
Standard Deviation 1.28
|
0.1 units on a scale
Standard Deviation 1.25
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 6
|
0.1 units on a scale
Standard Deviation 1.63
|
0.1 units on a scale
Standard Deviation 1.76
|
0.1 units on a scale
Standard Deviation 1.68
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 10)
|
0.0 units on a scale
Standard Deviation 1.70
|
0.0 units on a scale
Standard Deviation 1.68
|
0.0 units on a scale
Standard Deviation 1.69
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 14
|
-0.4 units on a scale
Standard Deviation 1.70
|
-0.2 units on a scale
Standard Deviation 1.82
|
-0.3 units on a scale
Standard Deviation 1.74
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 18
|
-0.3 units on a scale
Standard Deviation 1.73
|
-0.4 units on a scale
Standard Deviation 1.95
|
-0.3 units on a scale
Standard Deviation 1.81
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Week 22
|
-0.1 units on a scale
Standard Deviation 1.91
|
-0.2 units on a scale
Standard Deviation 1.90
|
-0.1 units on a scale
Standard Deviation 1.90
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit
Endpoint
|
0.0 units on a scale
Standard Deviation 1.87
|
0.1 units on a scale
Standard Deviation 1.96
|
0.0 units on a scale
Standard Deviation 1.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment PeriodPopulation: Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.
The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control. Endpoint refers to the last observation carried forward.
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=106 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
n=64 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
n=170 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 2
|
-0.1 units on a scale
Standard Deviation 0.95
|
0.1 units on a scale
Standard Deviation 1.18
|
0.0 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 6
|
0.1 units on a scale
Standard Deviation 1.34
|
0.0 units on a scale
Standard Deviation 1.52
|
0.1 units on a scale
Standard Deviation 1.41
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 10
|
-0.1 units on a scale
Standard Deviation 1.45
|
-0.1 units on a scale
Standard Deviation 1.43
|
-0.1 units on a scale
Standard Deviation 1.44
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 14
|
-0.3 units on a scale
Standard Deviation 1.27
|
-0.2 units on a scale
Standard Deviation 1.54
|
-0.2 units on a scale
Standard Deviation 1.37
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 18
|
-0.2 units on a scale
Standard Deviation 1.35
|
-0.4 units on a scale
Standard Deviation 1.57
|
-0.3 units on a scale
Standard Deviation 1.44
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Week 22
|
-0.2 units on a scale
Standard Deviation 1.54
|
-0.3 units on a scale
Standard Deviation 2.03
|
-0.3 units on a scale
Standard Deviation 1.74
|
—
|
—
|
|
Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit
Endpoint
|
-0.1 units on a scale
Standard Deviation 1.55
|
0.1 units on a scale
Standard Deviation 2.20
|
0.0 units on a scale
Standard Deviation 1.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)Population: Safety Analysis Set
Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).
Outcome measures
| Measure |
Placebo: Double-Blind Titration Period
n=182 Participants
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Hydrocodone ER: Double-Blind Titration Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks.
|
Placebo: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Adjustment Period
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks.
|
Hydrocodone ER: Open-Label Treatment Period
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Withdrawn From the Study For Lack of Efficacy
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
Hydrocodone ER - Titration/Adjustment Period
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Hydrocodone ER - Open-Label Treatment Period
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydrocodone ER - Titration/Adjustment Period
n=182 participants at risk
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
|
Hydrocodone ER - Open-Label Treatment Period
n=170 participants at risk
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.55%
1/182 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.00%
0/170 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
General disorders
Chest pain
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/182 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
0.59%
1/170 • Number of events 1 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
Other adverse events
| Measure |
Hydrocodone ER - Titration/Adjustment Period
n=182 participants at risk
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
|
Hydrocodone ER - Open-Label Treatment Period
n=170 participants at risk
Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.9%
9/182 • Number of events 9 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
7.1%
12/170 • Number of events 13 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
|
Gastrointestinal disorders
Nausea
|
10.4%
19/182 • Number of events 19 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
5.9%
10/170 • Number of events 12 • Titration/Adjustment period: Day 1 up to Week 4 Open-label Treatment period: Week 4 to Week 26
|
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