Trial Outcomes & Findings for A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED) (NCT NCT00605033)
NCT ID: NCT00605033
Last Updated: 2016-10-21
Results Overview
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
241 participants
Primary outcome timeframe
Assessed by Day 7 of double-blind, double-dummy treatment period.
Results posted on
2016-10-21
Participant Flow
Participant milestones
| Measure |
Suboxone
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
98
|
|
Overall Study
COMPLETED
|
136
|
90
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Suboxone
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Suboxone
n=143 Participants
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
n=97 Participants
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed by Day 7 of double-blind, double-dummy treatment period.Population: Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
Outcome measures
| Measure |
Suboxone
n=143 Participants
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
n=97 Participants
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
|---|---|---|
|
Response Rate
|
83.2 Percentage of participants
|
88.7 Percentage of participants
|
Adverse Events
Suboxone
Serious events: 2 serious events
Other events: 79 other events
Deaths: 0 deaths
Subutex
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suboxone
n=143 participants at risk
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
n=97 participants at risk
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.70%
1/143 • Number of events 1
|
0.00%
0/97
|
|
Nervous system disorders
Epilepsy
|
0.70%
1/143 • Number of events 1
|
1.0%
1/97 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt
|
0.70%
1/143 • Number of events 1
|
0.00%
0/97
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
|
Surgical and medical procedures
Drug detoxification
|
0.00%
0/143
|
1.0%
1/97 • Number of events 1
|
Other adverse events
| Measure |
Suboxone
n=143 participants at risk
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
Subutex
n=97 participants at risk
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
|
|---|---|---|
|
Eye disorders
Lacrimation increased
|
6.3%
9/143 • Number of events 9
|
1.0%
1/97 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
9/143 • Number of events 14
|
4.1%
4/97 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
8/143 • Number of events 8
|
1.0%
1/97 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
14.7%
21/143 • Number of events 29
|
7.2%
7/97 • Number of events 8
|
|
Gastrointestinal disorders
Toothache
|
0.70%
1/143 • Number of events 1
|
5.2%
5/97 • Number of events 5
|
|
General disorders
Asthenia
|
8.4%
12/143 • Number of events 15
|
7.2%
7/97 • Number of events 8
|
|
General disorders
Chills
|
7.0%
10/143 • Number of events 11
|
7.2%
7/97 • Number of events 7
|
|
General disorders
Fatigue
|
4.9%
7/143 • Number of events 8
|
5.2%
5/97 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
8/143 • Number of events 9
|
7.2%
7/97 • Number of events 7
|
|
Nervous system disorders
Headache
|
16.1%
23/143 • Number of events 30
|
12.4%
12/97 • Number of events 15
|
|
Psychiatric disorders
Anxiety
|
16.1%
23/143 • Number of events 27
|
16.5%
16/97 • Number of events 17
|
|
Psychiatric disorders
Drug dependence
|
7.0%
10/143 • Number of events 11
|
4.1%
4/97 • Number of events 6
|
|
Psychiatric disorders
Restlessness
|
4.2%
6/143 • Number of events 6
|
5.2%
5/97 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.5%
15/143 • Number of events 16
|
6.2%
6/97 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
8.4%
12/143 • Number of events 12
|
5.2%
5/97 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.6%
18/143 • Number of events 28
|
9.3%
9/97 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
6.3%
9/143 • Number of events 10
|
2.1%
2/97 • Number of events 3
|
|
Vascular disorders
Hot flush
|
7.0%
10/143 • Number of events 12
|
5.2%
5/97 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
8.4%
12/143 • Number of events 12
|
10.3%
10/97 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator will publish/present results together with other study sites, unless written permission is obtained from Sponsor. Investigator provides 45 days' written notice to Sponsor prior to submission for publication/presentation so that Sponsor can review copies of abstracts/manuscripts reporting results. Sponsor has the right to review/comment on any presentation regarding proprietary information, accuracy and fair balance of the information, and compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER