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Administrative reasons.
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The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
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 | Experimental | Buprenorphine transdermal patches 10 or 20 mcg/h |
|
| Placebo | Placebo Comparator | Placebo to match buprenorphine transdermal patch 10 or 20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch applied for 7-day wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase. | 483 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Clinical Research Consultants |
All subjects (N = 159) in the run-in period received BTDS 5 for the first 3 days, titrated to BTDS 10 or 20, continued stable nonopioid analgesic regimen for osteoarthritis (OA) pain, and took oxycodone immediate-release 5-mg capsules as supplemental analgesic therapy for primary OA pain site. N = 107 completed the run-in and were randomized.
12-Dec-2003 (First Patient First Visit) 02-Mar-2005 (Last Patient Last Visit of Extension). At the time of early termination, 39 centers had screened subjects, 22 centers had randomized subjects to the double-blind phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo Patch | Reference Treatment placebo 10 or 20 applied for 7-day wear |
| FG001 | Double-blind BTDS 10/20 | Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo transdermal patch | Drug | Placebo to match buprenorphine transdermal patch 10 or 20. |
|
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Winston Physician Services, Inc | Haleyville | Alabama | 35565 | United States |
| Private Practice | Muscle Shoals | Alabama | 35661 | United States |
| Clinic for Rheumatic Diseases | Tuscaloosa | Alabama | 35406 | United States |
| Radiant Research | Phoenix | Arizona | 85013 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| ACRC/Arizona Clinical Research | Tuscon | Arizona | 85715 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Southbay Pharma Research | Buena Park | California | 90620 | United States |
| Torrence Clinical Research | Torrance | California | 90505 | United States |
| Comprehensive Neuroscience Inc | Boynton Beach | Florida | 33437 | United States |
| Chiefland Medical Center | Chiefland | Florida | 32626 | United States |
| University Clinical Research Deland | DeLand | Florida | 32720 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32605 | United States |
| Drug Study Institute | Jupiter | Florida | 33458 | United States |
| Coastal Medical Research | Orange City | Florida | 32763 | United States |
| Ormond Medical Arts Pharmaceutical Res Ctr | Ormond Beach | Florida | 32174 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| Avancia Research | Pembroke Pines | Florida | 33024 | United States |
| Coastal Medical Research | Port Orange | Florida | 32127 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Gold Coast Research LLC | Weston | Florida | 33321 | United States |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | United States |
| Internal Medicine Northwest | Gurnee | Illinois | 60031 | United States |
| MediSphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| University of Louisville Medical/Rheumatology | Louisville | Kentucky | 40202 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| Future Care Studies | Springfield | Massachusetts | 01107 | United States |
| Bay Area Health Clinic | Bay City | Michigan | 48706 | United States |
| Medex Healthcare Research Inc | St Louis | Missouri | 63108 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Keystone Clinical Solutions | Altoona | Pennsylvania | 16602 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| BioMedical Research Associates | Shippensburg | Pennsylvania | 17257 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Low Country Rheumatology | Charleston | South Carolina | 29406 | United States |
| Brown Clinic | Watertown | South Dakota | 57201 | United States |
| Holston Medical Group | Bristol | Tennessee | 37620 | United States |
| CSS Research | Memphis | Tennessee | 38119 | United States |
| Prime Care Medical Center | Selmer | Tennessee | 38375 | United States |
| Team Research of Central Texas | Harker Heights | Texas | 76548 | United States |
| Quality Research | San Antonio | Texas | 78209 | United States |
| Advanced Pain Management and Rehab Hilltop Med Center | Virginia Beach | Virginia | 23454 | United States |
| Sentara Medical Group | Virginia Beach | Virginia | 23462 | United States |
| Physicians Clinic of Spokane | Spokane | Washington | 99204 | United States |
| FG002 | Run-in Period BTDS 5/10/20 | All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study. |
| FG003 | Extension Phase BTDS 5/10/20 | Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Placebo Patch | Reference Treatment placebo 10 or 20 applied for 7-day wear |
| BG001 | Double-blind BTDS | Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 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 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase. | The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment. | Posted | Number | participants | 483 days |
|
|
|
Subjects with AEs that were ongoing at subject's last study visit were followed until resolution or 30 days after last visit, whichever came first. AEs reported during 7 days following last visit were followed until resoultion or 30 days after last visit.
AEs were learned of through spontaneous reports and subject interview.
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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 Placebo Patch | Reference Treatment placebo 10 or 20 applied for 7-day wear | 1 | 51 | 14 | 51 | ||
| EG001 | Double-blind BTDS 10/20 | Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear | 2 | 56 | 22 | 56 | ||
| EG002 | Run-in Period | Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear | 1 | 159 | 60 | 159 | ||
| EG003 | Overall BTDS Exposure | Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase. | 5 | 159 | 82 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Acute myocardial infarction - DEATH | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | DEATH (systematic and nonsystematic assessments) |
|
| Cervical spinal stenosis | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Acute exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Recurrent Major Depression | Psychiatric disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Confusion | Psychiatric disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Near Syncope | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Chest Pain | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and non-systematic assessments. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site pruritus | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site erythema | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site rash | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Sweating Increased | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Somnolence | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dizziness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
This study was terminated early for administrative reasons. The efficacy data are not presented since the primary objective of this study was changed identifying it as a safety study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Executive Medical Director | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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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| Male |
|
| Serious adverse events |
|
| All Other Adverse Events in ≥ 4.5% of Subjects |
|