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NCT01871285 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
A Phase 2 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01871285: Completed Phase 2 study, sponsored by BioDelivery Sciences International.
NCT01871285 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01871285, a Phase 2 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study 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.
Primary Outcome
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Interventions
- DRUG Oxycodone
- DRUG Buprenorphine
- DRUG Placebo capsule
- DRUG Morphine sulfate
- DRUG Placebo film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01871285 record still lists
NCT01871285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 5 interventions - of which Oxycodone is the first listed.
NCT01871285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01871285 about?
NCT01871285 is a clinical study titled "Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film". 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 wi...
What is the current status of trial NCT01871285?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01871285?
The interventions under investigation include: Oxycodone (DRUG), Buprenorphine (DRUG), Placebo capsule (DRUG), Morphine sulfate (DRUG), Placebo film (DRUG).
Who is sponsoring clinical trial NCT01871285?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01871285's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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