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Buprenorphine marketed

Phase 2

Opioid Dependency | Small molecule | Psychiatry |Indivior Pharmaceuticals, Inc.|Last Updated: Apr 11, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Buprenorphine marketed · 1 trial · 1 indication

Phase 2 1
NCT01075971Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)Opioid Dependency
COMPLETED52 Analytics
PHASE2COMPLETED
Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)
Opioid Dependency
NCT0107597152
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Study Endpoints

Primary Endpoints

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.
Daily, Day 1 to Day 5

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).

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Buprenorphine hydrochlorideEXPERIMENTAL -

Interventions

NameTypeDescription
Buprenorphine hydrochloride marketed sublingual tablet (Subutex)DRUG8 mg or 16 mg daily, sublingual route on Days 1 and 2
Buprenorphine hydrochloride fast dissolving tablet (FDT)DRUG8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Patients must be at least (≥) 18 years of age, of either sex. * Patients treated for opioid dependence with Subutex®, with a stable d...

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