CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Buprenorphine +4 moredrug
Likely dose
Oxycodone 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01871285
NCT01871285Phase 2Completed
CompareCT.gov

An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film

BioDelivery Sciences International·interventional·Posted Jun 6, 2013·Updated Feb 27, 2017

In Brief

A Phase 2 clinical trial evaluating Buprenorphine, Placebo film, and 3 other interventions for Pain. Completed, enrolled 39 participants across 3 sites.

Detailed Summary

The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 6, 2013
Enrollment StartJun 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.1 years ago

Interventions

Buprenorphinedrug

Placebo filmdrug

Matching placebo buccal film

Oxycodonedrug

Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets

Morphine sulfatedrug

Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets

Placebo capsuledrug

Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets