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This study was terminated early due to administrative reasons.
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The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.
This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS 5 | Active Comparator | Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear |
|
| BTDS 20 | Experimental | Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs). | Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah O'Keefe, BSN | Purdue Pharma L.P., Stamford, CT | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Edwards Lake Medical Center |
Adult subjects (≥ 40 years), with osteoarthritis (OA) of the hip, knee or spine for longer than 1 year, controlled on oral opioid therapy, who met the inclusion/exclusion criteria specified in the protocol. The open-label run-in period (N = 188) selected subjects who tolerated BTDS 20 mcg/h and showed stable pain control (N = 96 completed).
07-Jan-2004 (First subject first visit); 09-Mar-2005 (last subject last visit of extension [subjects went directly into the extension upon completion of the double-blind phase]) at 42 sites in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in Period | (≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia. |
| FG001 | Double-blind BTDS 5 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Run-in Period |
|
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| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
|
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Rheumatogogy Associates of N. Alabama, | Huntsville | Alabama | 35801 | United States |
| Drug Research and Analysis Corp. | Montgomery | Alabama | 36106 | United States |
| Meadowbrook Research | Scottsdale | Arizona | 85251 | United States |
| Research Solutions, LLC | Searcy | Arizona | 72143 | United States |
| Central Arkansas Research | Hot Springs | Arkansas | 71913 | United States |
| Crest Clinical Research, Inc | Anaheim | California | 92804 | United States |
| NuLife Clinical Research, Inc. | Anaheim | California | 92805 | United States |
| Orange County Clinical Research | Cypress | California | 90630 | United States |
| Private Practice | Laguna Hills | California | 90404 | United States |
| Andwell Research | Laguna Niguel | California | 92677 | United States |
| Valerius Medical Group & Research Center Inc. | Long Beach | California | 90802 | United States |
| Anesthesiology and Pain Management | Los Gatos | California | 95032 | United States |
| Scripps Clinic Ranchro Bernardo | San Diego | California | 92128 | United States |
| Orrin M. Troum & Medical Associates | Santa Monica | California | 90404 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Private Practice | Arvada | Colorado | 80005 | United States |
| Mountainview Clinical Research | Denver | Colorado | 80209 | United States |
| Private Practice | Aventura | Florida | 33180 | United States |
| Medical Research Associates | Clearwater | Florida | 33761 | United States |
| LifeSpan Clinical Research | Miami | Florida | 33186 | United States |
| Ocala Rheumatology Research Center | Ocala | Florida | 34474 | United States |
| Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies | Saint Cloud | Florida | 34769 | United States |
| Wilker/Powers Center for Clinical Studies | Saint Cloud | Florida | 34769 | United States |
| Sarasota Arthritis Center | Sarasota | Florida | 34239 | United States |
| University Neurology | Sarasota | Florida | 34243 | United States |
| Pinnacle Trials, Inc. | Atlanta | Georgia | 30329 | United States |
| Clinical Investigative Services Med College of Georgia | Augusta | Georgia | 30912 | United States |
| America's Doctor (SMO) | Gurnee | Illinois | 60031 | United States |
| Dolby Providers, Inc. | New Orleans | Louisiana | 70128 | United States |
| Professional Clinical Research | Cadillac | Michigan | 49601 | United States |
| Private Practice | Oak Park | Michigan | 48237 | United States |
| Lake Michigan Clinical Research and Consulting, Inc. | Saint Joseph | Michigan | 49085 | United States |
| Research Center of the Ozarks, , MO | Everton | Missouri | 65646 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Cherry Hill Orthopedic Surgeons | Cherry Hill | New Jersey | 08002 | United States |
| Private Practice | Medford | New Jersey | 08055 | United States |
| Univeristy of Medicine and Dentistry of New Jersey | Stratford | New Jersey | 08084 | United States |
| Crescent Medical Assoc. | Astoria | New York | 11102 | United States |
| Private Practice | Plainview | New York | 11803 | United States |
| State University of NY at Stonybrook | Stony Brook | New York | 11794 | United States |
| Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Albermarle Family Practice | Elizabeth City | North Carolina | 27909 | United States |
| New Hanover Medical Research | Wilmington | North Carolina | 28412 | United States |
| Odyssey Research Services | Bismarck | North Dakota | 58501 | United States |
| Midwest Regional Research | Bellbrook | Ohio | 45305 | United States |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| Lyle, Austin Alexander PA | Tulsa | Oklahoma | 74104 | United States |
| Rouge Valley Clinical Research | Medford | Oregon | 97504 | United States |
| Southern Oregon Health & Wellness | Medford | Oregon | 97504 | United States |
| Keystone Clinical Solutions, Inc. | Altoona | Pennsylvania | 16602 | United States |
| Sidney Hillman Medical Center | Philadelphia | Pennsylvania | 19103 | United States |
| Arcuri Clinical Research | Philadelphia | Pennsylvania | 19142 | United States |
| The Arthritis & Osteoporosis Center | Orangeburg | South Carolina | 29118 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Integrity Clinical Research, LLC (SMO) | Milan | Tennessee | 38358 | United States |
| LifeTree Clinical Reseach | Salt Lake City | Utah | 84106 | United States |
| J. Lewis Research Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Arthritis Clinic of No. Virginia | Arlington | Virginia | 22205 | United States |
| MedSource | Richmond | Virginia | 23229 | United States |
| Vantage Clinical Research Group | Lacey | Washington | 98516 | United States |
| Arthritis Northwest | Seattle | Washington | 98166 | United States |
| Clinical Trials Northwest | Yakima | Washington | 98902 | United States |
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
| FG002 | Double-blind BTDS 20 | Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| FG003 | Extension Phase | Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Phase |
|
|
| Extension Phase |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind BTDS 5 | Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
| BG001 | Double-blind BTDS 20 | Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs). | The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study. | Posted | Number | Participants | Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) |
|
|
|
Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-blind BTDS 5 | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear | 1 | 47 | 17 | 47 | ||
| EG001 | Double-blind BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | 1 | 49 | 22 | 49 | ||
| EG002 | Open-label Run-in Period | The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase. | 2 | 188 | 52 | 188 | ||
| EG003 | Overall BTDS Exposure | Overall core and extension phase combined (run-in period, double-blind phase, and extension phase) | 6 | 188 | 101 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Chest pressure | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Somnolent | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Worsening of reflex sympathetic dystrophy | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Kidney stone | Renal and urinary disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Grade 2 splenic laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Right occipital condyle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Comminuted pelvic fracture left | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Right tibia-fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Sphenoid fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Comminuted acetabulum left | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Right lower lobe contusion on chest | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Left post distal shaft fibular fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Left lower lobe contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Subarachnoid hemorrhage of fourth ventricle | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Left hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Acute cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Edema peripheral | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Application site pruritus | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Application site erythema | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Application site rash | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
Study terminated due to administrative reasons. The primary objective was changed to a safety study prior to unblinding.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Executive Medical Director | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Adverse Event |
|
| Administrative |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Administrative |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Male |
|
| Serious adverse events |
|
| Other Adverse Events in ≥ 4.5% of subjects |
|