The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Public ClinicalTrials.gov record NCT00315445. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00315445
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Interventions
- Buprenorphine transdermal patch Drug
- Placebo oxycodone/acetaminophen tablets Drug
- OXY/APAP Drug
- Placebo transdermal patch (TDS) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 1997
- Primary completion
- Apr 30, 1998
- Completion
- Apr 30, 1998
- Last update posted
- Sep 2, 2012
1997 – 1998
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| Phoenix Center for Clinical Research | Phoenix | Arizona | 85015 | — |
| Phoenix Orthopedic Center, Ltd. | Phoenix | Arizona | 85023 | — |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | — |
| SeaView Research | Miami | Florida | 33134 | — |
| Park Place Therapeutic Center | Plantation | Florida | 33324 | — |
| Atlanta Research Center | Decatur | Georgia | 30033 | — |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | — |
| New Jersey Research Foundation | Linwood | New Jersey | 08221 | — |
| North Carolina Clinical Research, Inc. | Raleigh | North Carolina | 27607 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00315445, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2012 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00315445 live on ClinicalTrials.gov.