Trial Outcomes & Findings for Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time (NCT NCT01223365)
NCT ID: NCT01223365
Last Updated: 2017-06-05
Results Overview
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. 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
Day 1 of open-label titration period - Week 52 of the open-label treatment period
Results posted on
2017-06-05
Participant Flow
365 patients with chronic pain were screened for enrollment into this study: 25 patients were excluded on the basis of exclusion criteria, 6 withdrew consent, 2 were lost to follow up before the baseline visit, 1 patient did not meet an inclusion criteria, and 1 patient had an opioid violation because of self increasing analgesic medication.
330 enrolled patients came from 61 centers in the US: 166 rolled-over from study 3079, 52 were new opioid-naïve participants and 112 were new opioid-experienced participants. One enrolled patient was withdrawn before taking any study drug.
Participant milestones
| Measure |
Hydrocodone ER
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
|---|---|
|
Open-label Titration Period
STARTED
|
330
|
|
Open-label Titration Period
Safety Analysis Set
|
329
|
|
Open-label Titration Period
Achieved Stable Pain Relief
|
294
|
|
Open-label Titration Period
COMPLETED
|
291
|
|
Open-label Titration Period
NOT COMPLETED
|
39
|
|
Open-label Treatment Period
STARTED
|
291
|
|
Open-label Treatment Period
COMPLETED
|
189
|
|
Open-label Treatment Period
NOT COMPLETED
|
102
|
Reasons for withdrawal
| Measure |
Hydrocodone ER
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
|---|---|
|
Open-label Titration Period
Enrolled but not treated
|
1
|
|
Open-label Titration Period
Adverse Event
|
23
|
|
Open-label Titration Period
Lack of Efficacy
|
3
|
|
Open-label Titration Period
Withdrawal by Subject
|
5
|
|
Open-label Titration Period
Protocol Violation
|
1
|
|
Open-label Titration Period
Lost to Follow-up
|
2
|
|
Open-label Titration Period
Noncompliance with study drug admin
|
1
|
|
Open-label Titration Period
Noncompliance with study procedures
|
2
|
|
Open-label Titration Period
Starting physical therapy
|
1
|
|
Open-label Treatment Period
Adverse Event
|
39
|
|
Open-label Treatment Period
Lack of Efficacy
|
2
|
|
Open-label Treatment Period
Withdrawal by Subject
|
19
|
|
Open-label Treatment Period
Protocol Violation
|
15
|
|
Open-label Treatment Period
Lost to Follow-up
|
7
|
|
Open-label Treatment Period
Noncompliance with study drug admin
|
7
|
|
Open-label Treatment Period
Noncompliance with study procedures
|
6
|
|
Open-label Treatment Period
Moved out of area
|
2
|
|
Open-label Treatment Period
Negative urine drug screen when on treat
|
1
|
|
Open-label Treatment Period
"Out of window"
|
1
|
|
Open-label Treatment Period
Starting physical therapy
|
1
|
|
Open-label Treatment Period
Physician Decision
|
2
|
Baseline Characteristics
one participant data was missing the value
Baseline characteristics by cohort
| Measure |
Hydrocodone ER
n=330 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 11.51 • n=330 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=330 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
White
|
260 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Black
|
66 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and non-Latino
|
319 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=330 Participants
|
|
Weight
|
95.6 kg
STANDARD_DEVIATION 23.97 • n=329 Participants • one participant data was missing the value
|
|
Height
|
169.7 cm
STANDARD_DEVIATION 10.57 • n=329 Participants • one participant data was missing the value
|
|
Body Mass Index
|
33.1 kg/m^2
STANDARD_DEVIATION 7.38 • n=329 Participants • one participant data was missing the value
|
|
Type of Pain
Low back pain
|
113 Participants
n=330 Participants
|
|
Type of Pain
Back pain
|
103 Participants
n=330 Participants
|
|
Type of Pain
Osteoarthritis
|
82 Participants
n=330 Participants
|
|
Type of Pain
Diabetic peripheral neuropathy
|
12 Participants
n=330 Participants
|
|
Type of Pain
Postherpetic neuralgia
|
0 Participants
n=330 Participants
|
|
Type of Pain
Traumatic injury
|
3 Participants
n=330 Participants
|
|
Type of Pain
Neck pain
|
10 Participants
n=330 Participants
|
|
Type of Pain
Complex regional pain syndrome
|
3 Participants
n=330 Participants
|
|
Type of Pain
Rheumatoid arthritis
|
2 Participants
n=330 Participants
|
|
Type of Pain
Other
|
2 Participants
n=330 Participants
|
|
Duration Since Diagnosis
|
12.3 years
STANDARD_DEVIATION 9.54 • n=330 Participants
|
|
Duration on Opioid Therapy
|
4.4 years
STANDARD_DEVIATION 5.27 • n=330 Participants
|
PRIMARY outcome
Timeframe: Day 1 of open-label titration period - Week 52 of the open-label treatment periodPopulation: Safety analysis set
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. 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 |
New Opioid Experienced Subpopulation
n=112 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=165 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=329 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=52 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participants With Adverse Experiences
Any adverse event
|
98 Participants
|
135 Participants
|
284 Participants
|
51 Participants
|
|
Participants With Adverse Experiences
Treatment-related adverse event
|
69 Participants
|
63 Participants
|
173 Participants
|
41 Participants
|
|
Participants With Adverse Experiences
Death
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Adverse Experiences
Serious adverse event
|
16 Participants
|
7 Participants
|
27 Participants
|
4 Participants
|
|
Participants With Adverse Experiences
Withdrawals from treatment due to adverse event
|
24 Participants
|
20 Participants
|
62 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Week 52 of the open-label treatment periodPopulation: Posttitration Safety Analysis set. The posttitration safety analysis set included all patients who successfully completed the open label titration period and received 1 or more doses of study drug treatment in the open label treatment period.
Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * alanine aminotransferase (ALT): \>=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L * aspartate aminotransferase (AST): \>=3 times ULN. Normal range is 9-36 U/L * blood urea nitrogen (BUN): \>=10.71 mmol/L * creatinine: \>=177 μmol/L * uric acid: M\>=625, F\>=506 μmol/L * white blood cell count: \<=3.0\*10\^9/L * hemoglobin: M\<=115, F\<=95 g/dL * hematocrit: M\<0.37, F\<0.32 L/L * urine blood (hemoglobin): \>=2 unit increase from baseline * urine glucose: \>=2 unit increase from baseline
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=92 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=157 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=291 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=42 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
ALT
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
AST
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
BUN
|
3 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Creatinine
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Uric acid
|
4 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
White blood cell count
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Hemoglobin
|
3 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Hematocrit
|
6 Participants
|
6 Participants
|
14 Participants
|
2 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Urine blood
|
4 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Urine glucose
|
2 Participants
|
5 Participants
|
9 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 of open-label titration period - Week 52 of the open-label treatment periodPopulation: Safety analysis set. One rollover participant did not have vital signs values.
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 |
New Opioid Experienced Subpopulation
n=112 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=164 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=328 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=52 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Diastolic blood pressure - high
|
0 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Diastolic blood pressure - low
|
2 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Pulse - high
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Pulse - low
|
0 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Systolic blood pressure - high
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Systolic blood pressure - low
|
4 Participants
|
7 Participants
|
11 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment periodPopulation: Post-titration Safety analysis set. Only those participants with both baseline and visit electrocardiogram findings were summarized.
A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event. For overall results, the worst postbaseline finding for the participant was summarized. Results below are formatted as Baseline ECG result - Overall ECG result.
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=89 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=150 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=280 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=41 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Normal baseline - Normal overall
|
33 Participants
|
43 Participants
|
94 Participants
|
18 Participants
|
|
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Normal baseline - Abnormal overall
|
17 Participants
|
35 Participants
|
60 Participants
|
8 Participants
|
|
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Abnormal baseline - Normal overall
|
7 Participants
|
18 Participants
|
25 Participants
|
0 Participants
|
|
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Abnormal baseline - Abnormal overall
|
32 Participants
|
54 Participants
|
101 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periodsPopulation: Safety analysis set. The endpoint value is from the post-titration safety set (n=42, 92, 157, 291)
Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (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 |
New Opioid Experienced Subpopulation
n=112 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=165 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=329 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=52 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
>=1 CS value during study
|
30 Participants
|
36 Participants
|
76 Participants
|
10 Participants
|
|
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
>=1 CS value during open-label titration period
|
14 Participants
|
4 Participants
|
22 Participants
|
4 Participants
|
|
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
>=1 CS value at endpoint
|
8 Participants
|
13 Participants
|
23 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52Population: Full analysis set included all patients in the safety analysis set who had at least 1 postbaseline efficacy assessment. Participants contributing to each time point are listed in the time point label.
The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=92 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=157 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=291 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=42 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 4: Excellent
|
15 Participants
|
27 Participants
|
55 Participants
|
13 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 52: Poor
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 52: Fair
|
9 Participants
|
18 Participants
|
30 Participants
|
3 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 52: Good
|
36 Participants
|
62 Participants
|
115 Participants
|
17 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 52: Excellent
|
10 Participants
|
21 Participants
|
39 Participants
|
8 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Endpoint: Poor
|
6 Participants
|
8 Participants
|
17 Participants
|
3 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Endpoint: Fair (n=42, 92, 157, 291)
|
21 Participants
|
27 Participants
|
55 Participants
|
7 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Endpoint: Good
|
52 Participants
|
93 Participants
|
166 Participants
|
21 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Baseline: Poor
|
10 Participants
|
49 Participants
|
77 Participants
|
18 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Baseline: Fair
|
55 Participants
|
71 Participants
|
140 Participants
|
14 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Baseline: Good
|
18 Participants
|
29 Participants
|
48 Participants
|
1 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Baseline: Excellent
|
3 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 4: Poor
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 4: Fair
|
17 Participants
|
27 Participants
|
49 Participants
|
5 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Week 4: Good
|
54 Participants
|
94 Participants
|
168 Participants
|
20 Participants
|
|
Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status
Endpoint: Excellent
|
13 Participants
|
29 Participants
|
53 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment PeriodPopulation: Safety analysis set
SOAPP-R is a clinician-rated scale used to assess each patient's risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use. An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are * \<18 and * \<=18. Results indicate timeframe followed by risk cat
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=112 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=165 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=329 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=52 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
End of Open-Label Titration: >=18
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
End of Open-Label Titration: <18
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
Week 4: >=18
|
12 Participants
|
3 Participants
|
16 Participants
|
1 Participants
|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
Week 4: <18
|
73 Participants
|
134 Participants
|
246 Participants
|
39 Participants
|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
Week 24: >=18
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)
Week 24: <18
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52Population: Post-titration Safety Analysis set
The ABC was a clinician rated scale that consisted of a brief (21 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 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider's impression) was used in calculating 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). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=92 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=157 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=291 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=42 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Baseline
|
0.1 units on a scale
Standard Deviation 0.46
|
0.2 units on a scale
Standard Deviation 0.60
|
0.2 units on a scale
Standard Deviation 0.53
|
0.1 units on a scale
Standard Deviation 0.40
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
End of Titration
|
0.0 units on a scale
Standard Deviation 0.15
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.31
|
0.1 units on a scale
Standard Deviation 0.22
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 4
|
0.2 units on a scale
Standard Deviation 0.47
|
0.1 units on a scale
Standard Deviation 0.39
|
0.1 units on a scale
Standard Deviation 0.42
|
0.2 units on a scale
Standard Deviation 0.43
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 8
|
0.2 units on a scale
Standard Deviation 0.42
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.40
|
0.1 units on a scale
Standard Deviation 0.41
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 12
|
0.2 units on a scale
Standard Deviation 0.40
|
0.1 units on a scale
Standard Deviation 0.36
|
0.1 units on a scale
Standard Deviation 0.39
|
0.2 units on a scale
Standard Deviation 0.51
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 16
|
0.1 units on a scale
Standard Deviation 0.29
|
0.2 units on a scale
Standard Deviation 0.56
|
0.1 units on a scale
Standard Deviation 0.47
|
0.1 units on a scale
Standard Deviation 0.34
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 20
|
0.1 units on a scale
Standard Deviation 0.24
|
0.2 units on a scale
Standard Deviation 0.45
|
0.1 units on a scale
Standard Deviation 0.40
|
0.2 units on a scale
Standard Deviation 0.46
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 24
|
0.1 units on a scale
Standard Deviation 0.31
|
0.1 units on a scale
Standard Deviation 0.41
|
0.1 units on a scale
Standard Deviation 0.36
|
0.1 units on a scale
Standard Deviation 0.26
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 28
|
0.1 units on a scale
Standard Deviation 0.27
|
0.1 units on a scale
Standard Deviation 0.42
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.41
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 32
|
0.0 units on a scale
Standard Deviation 0.25
|
0.1 units on a scale
Standard Deviation 0.42
|
0.1 units on a scale
Standard Deviation 0.41
|
0.2 units on a scale
Standard Deviation 0.60
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 36
|
0.1 units on a scale
Standard Deviation 0.43
|
0.1 units on a scale
Standard Deviation 0.41
|
0.1 units on a scale
Standard Deviation 0.44
|
0.1 units on a scale
Standard Deviation 0.59
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 40
|
0.1 units on a scale
Standard Deviation 0.25
|
0.1 units on a scale
Standard Deviation 0.46
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.31
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 44
|
0.1 units on a scale
Standard Deviation 0.31
|
0.1 units on a scale
Standard Deviation 0.44
|
0.1 units on a scale
Standard Deviation 0.38
|
0.1 units on a scale
Standard Deviation 0.26
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 48
|
0.0 units on a scale
Standard Deviation 0.13
|
0.1 units on a scale
Standard Deviation 0.41
|
0.1 units on a scale
Standard Deviation 0.32
|
0.0 units on a scale
Standard Deviation 0.19
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 52
|
0.1 units on a scale
Standard Deviation 0.23
|
0.1 units on a scale
Standard Deviation 0.41
|
0.1 units on a scale
Standard Deviation 0.37
|
0.1 units on a scale
Standard Deviation 0.45
|
|
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Endpoint
|
0.2 units on a scale
Standard Deviation 0.60
|
0.2 units on a scale
Standard Deviation 0.59
|
0.2 units on a scale
Standard Deviation 0.58
|
0.2 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52Population: Post titration Safety Analysis set
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.
Outcome measures
| Measure |
New Opioid Experienced Subpopulation
n=92 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=157 Participants
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
Total Hydrocodone ER
n=291 Participants
Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
|
New Opioid Naïve Subpopulation
n=42 Participants
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
|---|---|---|---|---|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Baseline
|
5.4 units on a scale
Standard Deviation 4.61
|
3.7 units on a scale
Standard Deviation 3.70
|
4.4 units on a scale
Standard Deviation 4.31
|
5.1 units on a scale
Standard Deviation 5.29
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
End of Titration
|
4.0 units on a scale
Standard Deviation 3.66
|
2.1 units on a scale
Standard Deviation 2.74
|
3.0 units on a scale
Standard Deviation 3.26
|
3.8 units on a scale
Standard Deviation 3.37
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 4
|
3.7 units on a scale
Standard Deviation 3.70
|
2.3 units on a scale
Standard Deviation 2.83
|
2.9 units on a scale
Standard Deviation 3.21
|
3.2 units on a scale
Standard Deviation 3.06
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 8
|
3.9 units on a scale
Standard Deviation 4.12
|
2.4 units on a scale
Standard Deviation 2.96
|
2.8 units on a scale
Standard Deviation 3.36
|
2.4 units on a scale
Standard Deviation 2.44
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 12
|
4.2 units on a scale
Standard Deviation 3.99
|
2.4 units on a scale
Standard Deviation 2.71
|
3.1 units on a scale
Standard Deviation 3.28
|
3.1 units on a scale
Standard Deviation 3.12
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 16
|
4.0 units on a scale
Standard Deviation 4.84
|
2.3 units on a scale
Standard Deviation 2.82
|
2.9 units on a scale
Standard Deviation 3.53
|
2.4 units on a scale
Standard Deviation 1.98
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 20
|
3.5 units on a scale
Standard Deviation 3.78
|
2.1 units on a scale
Standard Deviation 2.80
|
2.6 units on a scale
Standard Deviation 3.13
|
2.6 units on a scale
Standard Deviation 2.49
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 24
|
3.9 units on a scale
Standard Deviation 4.14
|
2.4 units on a scale
Standard Deviation 3.04
|
2.9 units on a scale
Standard Deviation 3.42
|
2.6 units on a scale
Standard Deviation 2.66
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 28
|
3.3 units on a scale
Standard Deviation 3.66
|
2.3 units on a scale
Standard Deviation 2.91
|
2.6 units on a scale
Standard Deviation 3.09
|
2.1 units on a scale
Standard Deviation 2.10
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 32
|
2.8 units on a scale
Standard Deviation 3.07
|
2.0 units on a scale
Standard Deviation 2.62
|
2.3 units on a scale
Standard Deviation 2.69
|
2.3 units on a scale
Standard Deviation 1.84
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 36
|
3.2 units on a scale
Standard Deviation 3.35
|
2.3 units on a scale
Standard Deviation 3.30
|
2.7 units on a scale
Standard Deviation 3.22
|
2.9 units on a scale
Standard Deviation 2.44
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 40
|
3.0 units on a scale
Standard Deviation 3.20
|
2.1 units on a scale
Standard Deviation 2.97
|
2.5 units on a scale
Standard Deviation 3.09
|
2.8 units on a scale
Standard Deviation 3.21
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 44
|
2.7 units on a scale
Standard Deviation 2.86
|
2.2 units on a scale
Standard Deviation 3.41
|
2.4 units on a scale
Standard Deviation 3.06
|
2.3 units on a scale
Standard Deviation 1.90
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 48
|
3.0 units on a scale
Standard Deviation 3.98
|
2.3 units on a scale
Standard Deviation 3.19
|
2.5 units on a scale
Standard Deviation 3.37
|
2.4 units on a scale
Standard Deviation 2.57
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Week 52
|
3.0 units on a scale
Standard Deviation 3.30
|
2.3 units on a scale
Standard Deviation 3.05
|
2.5 units on a scale
Standard Deviation 3.04
|
2.4 units on a scale
Standard Deviation 2.39
|
|
Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status
Endpoint
|
4.2 units on a scale
Standard Deviation 4.41
|
2.5 units on a scale
Standard Deviation 3.25
|
3.2 units on a scale
Standard Deviation 3.78
|
3.5 units on a scale
Standard Deviation 3.74
|
Adverse Events
New Opioid Naïve Subpopulation
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
New Opioid Experienced Subpopulation
Serious events: 16 serious events
Other events: 83 other events
Deaths: 0 deaths
Rollover Subpopulation
Serious events: 7 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
New Opioid Naïve Subpopulation
n=52 participants at risk
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
New Opioid Experienced Subpopulation
n=112 participants at risk
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=165 participants at risk
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/24 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
2.3%
1/44 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/64 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Hemiparesis
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Urosepsis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
General disorders
Death
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Device related infection
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Infected cyst
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Listeria sepsis
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Sedation
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Speech disorder
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Tremor
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Psychiatric disorders
Impulsive behaviour
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
1.8%
2/112 • Number of events 2 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/112 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.00%
0/165 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
Other adverse events
| Measure |
New Opioid Naïve Subpopulation
n=52 participants at risk
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
|
New Opioid Experienced Subpopulation
n=112 participants at risk
The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
|
Rollover Subpopulation
n=165 participants at risk
The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
36.5%
19/52 • Number of events 22 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
31.2%
35/112 • Number of events 45 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
18.8%
31/165 • Number of events 43 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/52 • Number of events 2 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
7.1%
8/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
7.9%
13/165 • Number of events 19 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Nausea
|
30.8%
16/52 • Number of events 20 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
16.1%
18/112 • Number of events 25 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
17.0%
28/165 • Number of events 36 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
8/52 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.2%
7/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
9.7%
16/165 • Number of events 17 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
General disorders
Fatigue
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.2%
7/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.6%
6/165 • Number of events 6 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
General disorders
Oedema peripheral
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
5.4%
6/112 • Number of events 6 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
4.2%
7/165 • Number of events 8 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Bronchitis
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
7.1%
8/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.6%
6/165 • Number of events 8 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Influenza
|
9.6%
5/52 • Number of events 7 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
4.5%
5/112 • Number of events 5 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
2.4%
4/165 • Number of events 5 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
4/52 • Number of events 4 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.6%
4/112 • Number of events 5 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.1%
10/165 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Sinusitis
|
0.00%
0/52 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
5.4%
6/112 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.7%
11/165 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
5/52 • Number of events 5 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
5.4%
6/112 • Number of events 7 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
9.1%
15/165 • Number of events 16 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
8.0%
9/112 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.6%
6/165 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/52 • Number of events 2 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
8.9%
10/112 • Number of events 12 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
8.5%
14/165 • Number of events 15 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.2%
7/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.1%
10/165 • Number of events 13 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
5.4%
6/112 • Number of events 6 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
4.8%
8/165 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • Number of events 4 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.2%
7/112 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.6%
6/165 • Number of events 7 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Headache
|
15.4%
8/52 • Number of events 11 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
17.9%
20/112 • Number of events 24 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.1%
10/165 • Number of events 12 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Mental impairment
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.61%
1/165 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Nervous system disorders
Somnolence
|
17.3%
9/52 • Number of events 12 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
13.4%
15/112 • Number of events 16 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.7%
11/165 • Number of events 12 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52 • Number of events 3 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
5.4%
6/112 • Number of events 6 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
4.2%
7/165 • Number of events 8 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
6.2%
7/112 • Number of events 9 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
3.0%
5/165 • Number of events 5 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
|
Vascular disorders
Hypertension
|
7.7%
4/52 • Number of events 4 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
0.89%
1/112 • Number of events 1 • Day 1 of Open-label Titration period - Week 52 of the Open-label Treatment period
|
2.4%
4/165 • Number of events 4 • Day 1 of Open-label Titration period - Week 52 of the Open-label 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