Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Public ClinicalTrials.gov record NCT00531427. 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
Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
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 pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization 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
- NCT00531427
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 567 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 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
- Sep 2007 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Nov 2009 (Actual)
- Last update posted
- Sep 10, 2012
2007 – 2009
United States locations
- U.S. sites
- 87
- U.S. states
- 31
- U.S. cities
- 76
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| Catalina Research Institute | Chino | California | 91710 | — |
| Research Facility | Downey | California | 90241 | — |
| Research Facility | Foothill Ranch | California | 92610 | — |
| Research Facility | Laguna Hills | California | 92653 | — |
| Research Facility | Sacramento | California | 95831 | — |
| Research Facility | Littleton | Colorado | 80128 | — |
| Research Facility | Stamford | Connecticut | 06905 | — |
| Coastal Pain Management | Bradenton | Florida | 34209 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Research Facility | Clearwater | Florida | 33765 | — |
| Research Facility | Jupiter | Florida | 33458-7200 | — |
| Research Facility | Largo | Florida | 33765 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| Research Facility | Miami | Florida | 33135 | — |
| Research Facility | Orlando | Florida | 32806 | — |
| Research Facility | Plantation | Florida | 33324 | — |
| Research Facility | Royal Palm Hammock | Florida | 33411 | — |
| Clinical Research of West Flor | Tampa | Florida | 33603 | — |
| Research Facility | Tampa | Florida | 33613 | — |
| Research Facility | Venice | Florida | 34292 | — |
| Research Facility | West Palm Beach | Florida | 33409 | — |
| Research Facility | Atlanta | Georgia | 30342 | — |
| Research Facility | Augusta | Georgia | 30901 | — |
| AMR Research Associates | Bogart | Georgia | 30622-6821 | — |
| Research Facility | Dawsonville | Georgia | 30534 | — |
| Research Facility | Decatur | Georgia | 30033 | — |
| Research Facility | Marietta | Georgia | 30066 | — |
| Research Facility | Honolulu | Hawaii | 96814-4526 | — |
| Rehabilitation Association of IN | Indianapolis | Indiana | 46250 | — |
| Research Facility | Overland Park | Kansas | 66211 | — |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| Stat-Lab I, Inc. | Baton Rouge | Louisiana | 70808 | — |
| Research Facility | New Iberia | Louisiana | 70563 | — |
| Research Facility | New Orleans | Louisiana | 70114 | — |
| Research Facility | Frederick | Maryland | 21702 | — |
| Research Facility | Brockton | Massachusetts | 02301 | — |
| East Coast Clinical Research | Haverhill | Massachusetts | 01830-6141 | — |
| Research Facility | Springfield | Massachusetts | 01103 | — |
| Research Facility | Bay City | Michigan | 48706 | — |
| Premier Internal Medicine | Biloxi | Mississippi | 39531 | — |
| Research Facility | Florissant | Missouri | 63031 | — |
| Research Facility | St Louis | Missouri | 63117 | — |
| Sports Med Consultants PC | St Louis | Missouri | 63141 | — |
| Research Facility | Henderson | Nevada | 89014 | — |
| Research Facility | New York | New York | 10004 | — |
| Research Facility | New York | New York | 10022 | — |
| Research Facility | Morgantown | North Carolina | 28655 | — |
| Research Facility | Winston-Salem | North Carolina | 27103 | — |
| Research Facility | Canton | Ohio | 44718 | — |
| Research Facility | Cincinnati | Ohio | 45242 | — |
| Research Facility | Columbus | Ohio | 43213 | — |
| Research Facility | Columbus | Ohio | 43235 | — |
| Digestive Endoscopy Center | Dayton | Ohio | 45415 | — |
| Research Facility | Dayton | Ohio | 45432 | — |
| Research Facility | Middleburg Heights | Ohio | 44130 | — |
| Research Facility | Mount Gilead | Ohio | 43338 | — |
| Research Facility | Toledo | Ohio | 43623 | — |
| Research Facility | Oklahoma City | Oklahoma | 73109 | — |
| Research Facility | Eugene | Oregon | 97404 | — |
| Research Facility | Medford | Oregon | 97504-8311 | — |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | — |
| Research Facility | Duncansville | Pennsylvania | 16635 | — |
| Oyster Point Family Health Ctr | Lancaster | Pennsylvania | 17601 | — |
| Research Facility | Mechanicsburg | Pennsylvania | 17055 | — |
| Research Facility | West Reading | Pennsylvania | 19611 | — |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | — |
| Research Facility | Cranston | Rhode Island | 02920 | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29415 | — |
| Arthritis Clinic, PLLC | Jackson | Tennessee | 38305 | — |
| Research Facility | Austin | Texas | 78756 | — |
| Research Facility | Colleyville | Texas | 76034 | — |
| Research Facility | Dallas | Texas | 75230 | — |
| Research Facility | Nederland | Texas | 77627 | — |
| Research Facility | San Antonio | Texas | 78205-1116 | — |
| Research Facility | San Antonio | Texas | 78229 | — |
| Research Facility | Sugarland | Texas | 77479 | — |
| Research Facility | Salt Lake City | Utah | 84102 | — |
| NDC Medical Center | Norfolk | Virginia | 23502 | — |
| Independence Family Medicine | Virginia Beach | Virginia | 23455 | — |
| Pacific Northwest Primary Care | Tacoma | Washington | 98405 | — |
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 NCT00531427, 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 NCT00531427 live on ClinicalTrials.gov.