Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Public ClinicalTrials.gov record NCT00490919. 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
Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Study identification
- NCT ID
- NCT00490919
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 539 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
- Jun 2007 (Type not available)
- Primary completion
- Jul 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Sep 10, 2012
2007 – 2008
United States locations
- U.S. sites
- 86
- U.S. states
- 29
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Facility | Anniston | Alabama | 36207 | — |
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Radiant Research; Phoenix Southeast | Chandler | Arizona | 85225 | — |
| Arizona Research Center Inc. | Phoenix | Arizona | 85023 | — |
| Research Facility | Phoenix | Arizona | 85029 | — |
| Research Facility | Phoenix | Arizona | 85032 | — |
| Research Facility | Anaheim | California | 92801 | — |
| Lovelace Scientific Resources, Inc. | Beverly Hills | California | 90211 | — |
| Research Facility | Carmichael | California | 95608 | — |
| Advance Care Medical Group | City of Industry | California | 91748 | — |
| Research Facility | Downey | California | 90241 | — |
| Research Facility | Foothill Ranch | California | 92610 | — |
| Research Facility | Sacramento | California | 95831 | — |
| Research Facility | San Luis Obispo | California | 93405 | — |
| Research Facility | Littleton | Colorado | 80128 | — |
| Research Facility | Stamford | Connecticut | 06905 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Research Facility | Clearwater | Florida | 33765 | — |
| University Clinical Research | DeLand | Florida | 32720 | — |
| Arthritis Associates of S. FL | Delray Beach | Florida | 33484 | — |
| Research Facility | Fort Myers | Florida | 33907 | — |
| Century Clinical Research, Inc. | Holly Hill | Florida | 32117-2257 | — |
| Research Facility | Jupiter | Florida | 33458-7200 | — |
| Research Facility | Largo | Florida | 33770 | — |
| Research Facility | Merritt Island | Florida | 32953 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| Research Facility | Orlando | Florida | 32806 | — |
| Research Facility | Plantation | Florida | 33324 | — |
| Research Facility | Port Orange | Florida | 32127 | — |
| Clinical Research of West Flor | Tampa | Florida | 33603 | — |
| Research Facility | Tampa | Florida | 33613 | — |
| Research Facility | West Palm Beach | Florida | 33409 | — |
| Independent Neurodiagnostic Clinic | Atlanta | Georgia | 30327 | — |
| Research Facility | Dawsonville | Georgia | 30534 | — |
| Druid Oaks Health Center | Decatur | Georgia | 30033 | — |
| Research Facility | Marietta | Georgia | 30060 | — |
| Research Facility | Marietta | Georgia | 30066 | — |
| Research Facility | Honolulu | Hawaii | 96814-4526 | — |
| Research Facility | Boise | Idaho | 83702 | — |
| Rehabilitation Association of IN | Indianapolis | Indiana | 46250 | — |
| Research Facility | Overland Park | Kansas | 66211 | — |
| CTT Consultants, Inc. | Prairie Village | Kansas | 66206 | — |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | — |
| Research Facility | New Orleans | Louisiana | 70114 | — |
| Research Facility | New Orleans | Louisiana | 70115 | — |
| Research Facility | Shreveport | Louisiana | 71103 | — |
| Research Facility | Brockton | Massachusetts | 02301 | — |
| East Coast Clinical Research | Haverhill | Massachusetts | 01830-6141 | — |
| Research Facility | Springfield | Massachusetts | 01103 | — |
| Research Facility | Bay City | Michigan | 48706 | — |
| Research Facility | Biloxi | Mississippi | 39531 | — |
| Research Facility | Florissant | Missouri | 63031 | — |
| Research Facility | St Louis | Missouri | 63117 | — |
| Research Facility | St Louis | Missouri | 63141 | — |
| Sports Med Consultants, PC | St Louis | Missouri | 63141 | — |
| Research Facility | Henderson | Nevada | 89014 | — |
| Research Facility | Las Vegas | Nevada | 89123 | — |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | — |
| Research Facility | New York | New York | 10004 | — |
| Research Facility | New York | New York | 10022 | — |
| Research Facility | Charlotte | North Carolina | 28209 | — |
| Research Facility | Greensboro | North Carolina | 27401 | — |
| Research Facility | Morgantown | North Carolina | 28655 | — |
| Research Facility | Cincinnati | Ohio | 45242 | — |
| Community Research | Cincinnati | Ohio | 45245 | — |
| Research Facility | Columbus | Ohio | 43213 | — |
| Research Facility | Columbus | Ohio | 43235 | — |
| Research Facility | Toledo | Ohio | 43623 | — |
| Research Facility | Oklahoma City | Oklahoma | 73109 | — |
| Research Facility | Eugene | Oregon | 97404 | — |
| Research Facility | Medford | Oregon | 97504-8311 | — |
| Research Facility | Altoona | Pennsylvania | 16602 | — |
| Research Facility | Chicora | Pennsylvania | 16025 | — |
| Research Facility | Duncansville | Pennsylvania | 16635 | — |
| Research Facility | Mechanicsburg | Pennsylvania | 17055 | — |
| Research Facility | West Reading | Pennsylvania | 19611 | — |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | — |
| Anderson Family Care, PA | Anderson | South Carolina | 29621 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Research Facility | Killeen | Texas | 76543 | — |
| Research Facility | Plano | Texas | 75093 | — |
| Research Facility | San Antonio | Texas | 78205-1116 | — |
| Research Facility | San Antonio | Texas | 78229 | — |
| Research Facility | Sugarland | Texas | 77479 | — |
| Research Facility | Salt Lake City | Utah | 84106 | — |
| Research Facility | Roanoke | Virginia | 24018 | — |
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 NCT00490919, 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 10, 2012 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00490919 live on ClinicalTrials.gov.