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NCT01125917 · ClinicalTrials.gov registry record · Phase 3
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
NCT01125917: Clinical Trial Phase 3 study, sponsored by Purdue Pharma.
NCT01125917 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 354 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125917, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
Study Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.
Primary Outcome
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2004-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
Why NCT01125917 stopped before completion
NCT01125917 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01125917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125917 about?
NCT01125917 is a clinical study titled "Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015". The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief ...
What is the current status of trial NCT01125917?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2004-06. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01125917?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT01125917?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01125917's enrollment target sits among peer trials
354 1026th of 2000 higher than 973 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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