Trial Outcomes & Findings for Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED) (NCT NCT00684073)

Results Overview

Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Each treatment Day (post-dose on days 1-5)

Results posted on

2023-03-20

60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent

Participant milestones
Measure	Subutex®/Suboxone® Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Selection STARTED	60
Selection COMPLETED	53
Selection NOT COMPLETED	7
Treatment (Days 1 Through 5) STARTED	53
Treatment (Days 1 Through 5) COMPLETED	52
Treatment (Days 1 Through 5) NOT COMPLETED	1

Reasons for withdrawal
Measure	Subutex®/Suboxone® Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Selection Selection/non-selection criteria	3
Selection Death	1
Selection noncompliance	1
Selection Lost to Follow-up	1
Selection request of the sponsor	1
Treatment (Days 1 Through 5) non-respect of eligibility criteria	1

Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

Baseline characteristics by cohort
Measure	Subutex®/Suboxone® n=53 Participants Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Age, Continuous	38.9 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

Timeframe: Each treatment Day (post-dose on days 1-5)

Population: Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.

Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"

Outcome measures
Measure	Day 1 (Subutex®) n=53 Participants All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	Day 2 (Subutex®) n=53 Participants All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	Day 3 (Suboxone®) n=53 Participants All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	Day 4 (Suboxone®) n=53 Participants All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	Day 5 (Suboxone®) n=53 Participants All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).	7.04 centimeters Standard Deviation 2.24	6.83 centimeters Standard Deviation 2.18	7.38 centimeters Standard Deviation 1.93	6.89 centimeters Standard Deviation 2.48	7.12 centimeters Standard Deviation 2.26

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Subutex®/Suboxone® n=53 participants at risk Subutex® for first two days of study followed by Suboxone® for last 3 days of study
General disorders Fatigue	7.5% 4/53 • Number of events 4
Nervous system disorders Headache	5.7% 3/53 • Number of events 3
Skin and subcutaneous tissue disorders Hyperhidrosis	5.7% 3/53 • Number of events 3

Schering-Plough

Principal investigator is a sponsor employee The sponsor agreement is always necessary before PI publishing or communications. The sponsor can review the communication project during 28 days. The sponsor can require changes to the communication and can extend the embargo.
Publication restrictions are in place

Restriction type: OTHER