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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 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 354 participants.
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.
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2004-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01125917
The ClinicalTrials.gov registry entry for NCT01125917 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01125917 reports 0 study locations.
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.
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