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NCT00315445 · ClinicalTrials.gov registry record · Phase 3
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT00315445 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 134 participants.
The verdict
NCT00315445, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Placebo oxycodone/acetaminophen tablets
- DRUG OXY/APAP
- DRUG Placebo transdermal patch (TDS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 1997-12 |
| Est. Completion | 1998-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315445
The ClinicalTrials.gov registry entry for NCT00315445 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 134 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 4 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT00315445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315445 about?
NCT00315445 is a clinical study titled "The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.". The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days durin...
What is the current status of trial NCT00315445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 1997-12. Estimated completion is 1998-05.
What interventions are being tested in trial NCT00315445?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Placebo oxycodone/acetaminophen tablets (DRUG), OXY/APAP (DRUG), Placebo transdermal patch (TDS) (DRUG).
Who is sponsoring clinical trial NCT00315445?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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