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NCT00313014 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
NCT00313014 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 660 participants.
The verdict
NCT00313014, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.
Interventions
- DRUG Buprenorphine
- DRUG Oxycodone Immediate-Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00313014
The ClinicalTrials.gov registry entry for NCT00313014 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 660 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 2 interventions - of which Buprenorphine is the first listed.
NCT00313014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00313014 about?
NCT00313014 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with o...
What is the current status of trial NCT00313014?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2004-02. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00313014?
The interventions under investigation include: Buprenorphine (DRUG), Oxycodone Immediate-Release (DRUG).
Who is sponsoring clinical trial NCT00313014?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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