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The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
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 patch 5, 10 or 20 micrograms/hour (mcg/h) |
|
| Placebo | Placebo Comparator | Placebo to match BTDS 5, 10 or 20 mcg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. | Inadequate analgesia:
| Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site | The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine). |
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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 |
|---|---|---|---|---|---|---|
| Vista Medical Research | Mesa | Arizona | 85206 | United States | ||
| Arizona Research Center |
529 subjects began the run-in period with buprenorphine transdermal system (BTDS) 5 and their dose was titrated to BTDS 10 or 20 to achieve effective pain control. Subjects meeting criteria for adequate analgesia within 21 days were randomized into the double-blind phase (the number of subjects [N] = 328 completed run-in period).
25-Apr-2003 (first patient first visit) to 01-Jun-2004 (last patient last visit).
This study was conducted at 41 medical/research sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo | Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear. |
| FG001 | Double-blind BTDS | Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. |
|
| 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Radiant Research | Phoenix | Arizona | 85013 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| ACRC/Arizona Clinical Research | Tucson | Arizona | 85715 | United States |
| Advance Pain Medicine | Bakersfield | California | 93311 | United States |
| Eastgate Medical Center | Cypress | California | 90623 | United States |
| University Osteoporosis Ctr | Loma Linda | California | 92354 | United States |
| San Diego Arthritis & Osteoporosis Medical Clinic | San Diego | California | 92108 | United States |
| Scripps Clinic Rancho Bernard | San Diego | California | 92128 | United States |
| CNS Clinical Trials, Inc | San Francisco | California | 94121 | United States |
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States |
| Integrative Treatment Centers/Rocky Mtn Clin Res | Westminster | Colorado | 80021 | United States |
| Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| Stamford Therapeutic Consortium | Bridgeport | Connecticut | 66060 | United States |
| Medical Specialists of the Palm Beaches | Atlantis | Florida | 33462 | United States |
| University Clinical Research Deland | DeLand | Florida | 32720 | United States |
| Drug Study Institute | Jupiter | Florida | 33458 | United States |
| Coastal Medical Research | Orange City | Florida | 32763 | 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 | Weston | Florida | 33331 | United States |
| Non-Surgical Orthopedic & Spine Center | Marietta | Georgia | 30060 | United States |
| Columbus Internal Medical Associates | Columbus | Indiana | 47201 | United States |
| MediSphere Medical Research Ctr. | Evansville | Indiana | 47714 | United States |
| Primary Care Research | Murray | Kentucky | 42071 | United States |
| Professional Clinical Research | Cadillac | Michigan | 49601 | United States |
| Sound Medical At West Front Primary Care | Traverse City | Michigan | 49684 | United States |
| Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care | New York | New York | 10003 | United States |
| All-Trials Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Keystone Clinical | Altoona | Pennsylvania | 16602 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Clinical Research Center of Reading, LLP | West Reading | Pennsylvania | 19611 | United States |
| Low Country Rheumatology | Charleston | South Carolina | 29406 | United States |
| Brown Clinic | Watertown | South Dakota | 57201 | United States |
| Private Practice | Dallas | Texas | 75251 | United States |
| Team Research of Central Texas | Harker Heights | Texas | 76548 | United States |
| Radiant Research San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| ACCU Clinical Research Trials, Inc | Seguin | Texas | 78155 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Advance Pain Management & Rehab | Virgina Beach | Virginia | 23454 | United States |
| Evergreen Clinical Research Associates | Edmonds | Washington | 98026 | United States |
| Internal Medicine Northwest | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Placebo | Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear. |
| BG001 | Double-blind BTDS | Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 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 | The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. | Inadequate analgesia:
| The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase. | Posted | Mean | Standard Error | days | Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods |
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| Secondary | Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site | The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine). | Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase. | Posted | Mean | Standard Error | units on a scale | 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. |
|
Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
Adverse events (AEs) were recorded 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 5, 10, or 20 | Reference treatment in the double-blind phase | 0 | 162 | 15 | 162 | ||
| EG001 | Double-blind BTDS 5, 10, or 20 | Test treatments in the double-blind phase | 1 | 164 | 28 | 164 | ||
| EG002 | Open-label Run-in Period BTDS 5, 10, or 20 | Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase. | 6 | 529 | 229 | 529 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intermittent complete heart block | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Pneumonia | Infections and infestations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Left foot cellulitis | Infections and infestations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Acute upper respiratory tract infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Elevated blood pressure | Investigations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Numbness left side of face | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Tremulousness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Worsening of hypertension | Vascular disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| 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 |
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| Vomiting not otherwise specified (NOS) | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Application site erythema | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Application site pruritus | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Dizziness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Somnolence | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, 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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| Male |
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| Units | Counts |
|---|
| Participants |
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