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NCT00320801 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
A Phase 3 study, sponsored by Purdue Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT00320801 is a Phase 3 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 188 participants.
The verdict
NCT00320801, a Phase 3 study, was terminated before completion, sponsored by Purdue Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00320801
The ClinicalTrials.gov registry entry for NCT00320801 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 188 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.
NCT00320801 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00320801 about?
NCT00320801 is a clinical study titled "Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.". The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treat...
What is the current status of trial NCT00320801?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2004-01. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00320801?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00320801?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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