The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Public ClinicalTrials.gov record NCT00315887. 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 Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets 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 and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.
Study identification
- NCT ID
- NCT00315887
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
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
- Apr 1999 (Type not available)
- Primary completion
- Not listed
- Completion
- Oct 1999 (Type not available)
- Last update posted
- May 3, 2006
1999
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Arthritis Center of Connecticut | Waterbury | Connecticut | 06708 | — |
| University Clinical Research | DeLand | Florida | 32720 | — |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | — |
| Miami Research Associates | Miami | Florida | 33173 | — |
| Sarasota Arthritis Center | Sarasota | Florida | 34239 | — |
| Coastal Medical Research | South Daytona Beach | Florida | 32119 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Private Practice | Weston | Florida | 33331 | — |
| Pain Management & Rehabilitation | Terre Haute | Indiana | 47807 | — |
| Mid-America Rheumatology Consultants | Overland Park | Kansas | 66209 | — |
| Riverhills Healthcare | Crestview Hills | Kentucky | 41017 | — |
| Arthritis & Osteoporosis Treatment & Research Center | Jackson | Mississippi | 39216 | — |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| PrecisionMed, Inc. | Las Vegas | Nevada | 89128 | — |
| Cornerstone Research Care | High Point | North Carolina | 27262 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Center for Clinical Research | Austin | Texas | 78758 | — |
| The Arthritis Clinic of Northern Virginia | Arlington | Virginia | 22206 | — |
| Evergreen Clinical Research | Edmonds | Washington | 98026 | — |
| Private Practice | Wauwatosa | Wisconsin | 53226 | — |
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 NCT00315887, 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 May 3, 2006 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00315887 live on ClinicalTrials.gov.