The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Public ClinicalTrials.gov record NCT00315874. 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
Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
Study identification
- NCT ID
- NCT00315874
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 225 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
- Mar 31, 1997
- Primary completion
- Not listed
- Completion
- Dec 31, 1997
- Last update posted
- May 13, 2013
1997 – 1998
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hawthorne & York, Intl, Ltd | Phoenix | Arizona | 85008 | — |
| Arizona Research & Education | Phoenix | Arizona | 85012 | — |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | — |
| Park Place Therapeutic Center | Plantation | Florida | 33324 | — |
| Atlanta Research Center | Atlanta | Georgia | 30033 | — |
| Rheumatology Associates, Inc. | Indianapolis | Indiana | 46260 | — |
| Westside Family Medical Center | Kalamazoo | Michigan | 49009 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| The New York Hospital Cornell Medical Center | New York | New York | 10021 | — |
| NC Clinical Research, Inc. | Raleigh | North Carolina | 27607 | — |
| Pain Control Ctr Bowman Gray School of Med | Winston-Salem | North Carolina | 27103 | — |
| 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 NCT00315874, 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 13, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00315874 live on ClinicalTrials.gov.