Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Public ClinicalTrials.gov record NCT01125917. 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 Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.
Study identification
- NCT ID
- NCT01125917
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 354 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 2004 (Type not available)
- Primary completion
- Sep 2005 (Actual)
- Completion
- Jan 2008 (Actual)
- Last update posted
- Sep 3, 2012
2004 – 2008
United States locations
- U.S. sites
- 84
- U.S. states
- 32
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pain Center | Birmingham | Alabama | 35244 | — |
| Arthritis Clinical Intervention Program | Birmingham | Alabama | 35249 | — |
| Winston Physician Services, Inc | Haleyville | Alabama | 35565 | — |
| Arizona Research Center Inc | Phoenix | Arizona | 85023 | — |
| Radiant Research | Phoenix | Arizona | 85029 | — |
| Advanced Clinical Therapeutics | Tucson | Arizona | 85712 | — |
| Hot Springs Pain Clinic | Hot Springs | Arkansas | 71913 | — |
| NuLife Clinical Research, Inc. | Anaheim | California | 92805 | — |
| Lovelace Scientific Resources | Beverly Hills | California | 90211 | — |
| Northern California Research Corp | Carmichael | California | 95608 | — |
| International Clinical Research Network | Chula Vista | California | 91911 | — |
| Shreenath Clinical Service | Fountain Valley | California | 92708 | — |
| U of Calif at Davis, Med Ctr, Pain Management Center | Sacramento | California | 95817 | — |
| Accelovance | San Diego | California | 92108 | — |
| Southern Colorado Clinic | Pueblo | Colorado | 81008 | — |
| Chiefland Medical Center | Chiefland | Florida | 32626 | — |
| University Clinical Research Deland | DeLand | Florida | 32720 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Innovative Research of West Florida, Inc. | Largo | Florida | 33770 | — |
| Renstar Medical | Ocala | Florida | 34471 | — |
| Peninsula Research Inc. | Ormond Beach | Florida | 32174 | — |
| The Arthritis Center | Palm Harbor | Florida | 34684 | — |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33324 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | — |
| Atlanta Knee & Shoulder Clinic | Stockbridge | Georgia | 30281 | — |
| Pain Care Boise | Boise | Idaho | 83702 | — |
| Idaho Arthritis and Osteoporosis Center | Meridian | Idaho | 83742 | — |
| Pain and Rehabilitation Clinic of Chicago | Chicago | Illinois | 60610 | — |
| GFI Research Center | Evansville | Indiana | 47714 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| Medical Associates Clinics | Dubuque | Iowa | 52002 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | — |
| CTT, Inc. | Prairie Village | Kansas | 66206 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| New Orleans Clinical Trial Management Inc. | Metairie | Louisiana | 70006 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| Best Clinical Trials, LLC | New Orleans | Louisiana | 70115 | — |
| Research Center of Louisiana | New Orleans | Louisiana | 70115 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Future Care Studies | Springfield | Massachusetts | 01103 | — |
| Rheumatology PC | Kalamazoo | Michigan | 49009 | — |
| Lake Michigan Clinical Research & Consulting, Inc. | Saint Joseph | Michigan | 49085 | — |
| Medex Healthcare Research Inc | St Louis | Missouri | 63108 | — |
| HealthCare Research | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Lovelace Scientific Resources | Henderson | Nevada | 89014 | — |
| Pivotal Research Centers | North Las Vegas | Nevada | 89030 | — |
| Research Across America | New York | New York | 10022 | — |
| Pain and Orthopedic Neurology , Charlotte Spine Center, | Charlotte | North Carolina | 28207 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| Triangle Orthopaedic Associates | Durham | North Carolina | 27704 | — |
| Pharmquest | Greensboro | North Carolina | 27401 | — |
| MedArk Clinical Research | Morgantown | North Carolina | 28655 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Odyssey Research | Bismarck | North Dakota | 58502 | — |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | — |
| Associated Medical Services Inc | Oklahoma City | Oklahoma | 73112 | — |
| Keystone Clinical Research | Altoona | Pennsylvania | 16602 | — |
| Valley Pain Specialists | Bethlehem | Pennsylvania | 18016 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Central Pennsylvania Clinical Research | Mechanicsburg | Pennsylvania | 17055 | — |
| BioMedical Research Associates | Shippensburg | Pennsylvania | 17257 | — |
| University Orthopedics Center | State College | Pennsylvania | 16801 | — |
| New England Center Clinical Research | Cranston | Rhode Island | 29200 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| The Arthritis and Osteoporosis Center | Orangeburg | South Carolina | 29118 | — |
| Brown Clinic | Watertown | South Dakota | 57201 | — |
| Holston Medical Group | Bristol | Tennessee | 37620 | — |
| Tri Cities Medical Research | Bristol | Tennessee | 37620 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Galenos Research | Dallas | Texas | 75251 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Team Research of Central Texas | Harker Heights | Texas | 76548 | — |
| KRK Medical Research | Richardson | Texas | 75080 | — |
| Benchmark Research | San Angelo | Texas | 76904 | — |
| Unlimited Research | San Antonio | Texas | 78233 | — |
| Texas Medical Research Associates | San Antonio | Texas | 78238 | — |
| Clinical Trial Network Oaks Medical Center | Spring | Texas | 77386 | — |
| N. Texas Neuro Research | Wichita Falls | Texas | 76301 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
| Dean Medical Center | Oregon | Wisconsin | 53575 | — |
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 NCT01125917, 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 3, 2012 · Synced Oct 17, 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 NCT01125917 live on ClinicalTrials.gov.