Trial Outcomes & Findings for Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED) (NCT NCT01075971)

Last Updated: 2023-04-11

Results Overview

Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from "Not at all satisfied" (score = 0) to "Totally satisfied" (score = 10).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Daily, Day 1 to Day 5

Results posted on

2023-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine Hydrochloride 8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine Hydrochloride n=52 Participants 8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
Age, Continuous	37.94 years STANDARD_DEVIATION 7.58 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment France	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily, Day 1 to Day 5

Outcome measures

Outcome measures
Measure	Buprenorphine Hydrochloride n=52 Participants 8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Day 1 Marketed SL	6.01 Score on a scale Standard Deviation 2.42
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Day 2 Marketed SL	5.91 Score on a scale Standard Deviation 2.24
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Day 3 FTD	7.73 Score on a scale Standard Deviation 1.77
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Day 4 FTD	7.75 Score on a scale Standard Deviation 1.74
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Day 5 FTD	7.72 Score on a scale Standard Deviation 1.76
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Overall SL formulation	5.96 Score on a scale Standard Deviation 2.32
The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. Overall FTD formulation	7.73 Score on a scale Standard Deviation 1.74

Adverse Events

Buprenorphine Hydrochloride

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Buprenorphine Hydrochloride n=52 participants at risk 8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
Nervous system disorders Headache	5.8% 3/52 • Number of events 3 • All adverse events, including AEs that started before the first dose.

Additional Information

Head, Clinical Trials Registry & Results Disclosure Group

Schering-Plough

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER