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The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS 5, 10 or 20 | Experimental | Buprenorphine transdermal patch |
|
| 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 |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded. | 28 weeks |
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Inclusion Criteria:
Include:
Exclusion Criteria:
Include:
Refer to core study for additional inclusion/exclusion information.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center Inc. | Phoenix | Arizona | 85023 | United States | ||
| Clinical Research Consultants Inc |
Adult subjects aged ≥ 18 years, with chronic nonmalignant pain, controlled on oral opioid therapy. Subjects in the US who participated in the BUP3201 core study and met the criteria per Amendment 2, and subjects in the UK who participated in the BUP3201 core and met the inclusion/ exclusion criteria, were able to participate in the extension.
16-Apr-2001 (first patient first visit) 27-Feb-2002 (last patient last visit). The extension phase of study was conducted at 20 sites in the US Baseline Period: and 18 sites in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Extension Phase | Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Trumbull |
| Connecticut |
| 06611 |
| United States |
| Tampa Bay Medical Research Inc | Clearwater | Florida | 33761 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| University Clinical Research Deland | DeLand | Florida | 32720 | United States |
| University Clinical Research Inc, | Pembroke Pines | Florida | 33024 | United States |
| Gold Coast Research, LLC | Plantation | Florida | 33324 | United States |
| Gold Coast Research LLC | Tamarac | Florida | 33321 | United States |
| Family Medicine Associates | Evansville | Indiana | 47712 | United States |
| Pain Management & Rehabilitation | Terre Haute | Indiana | 47807 | United States |
| Southeastern Center for Headache and Pain | Crestview Heights | Kentucky | 41017 | United States |
| Westside Family Medical Center PC | Kalamazoo | Michigan | 49009 | United States |
| The Arthritis Clinic | Charlotte | North Carolina | 28211 | United States |
| Cornerstone Research Care | High Point | North Carolina | 27262 | United States |
| ALL-TRIALS Clinical Research LLC | Winston-Salem | North Carolina | 27103 | United States |
| Summit Research Solutions | Memphis | Tennessee | 38119 | United States |
| Radiant Research - Austin | Austin | Texas | 78758 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Clinical Research Management | New Berlin | Wisconsin | 53151 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extension Phase (BTDS 5, 10 or 20) | Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear. |
| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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. | Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded. | The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase. | Posted | Number | participants | 28 weeks |
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All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained 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 | Total Extension Phase | Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear. | 16 | 189 | 143 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Asthenia | General disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Back pain | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Hernia | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Vascular disorder | Vascular disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Cardiovascular disorder | Cardiac disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Congestive heart failure | Cardiac disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Myocardial infarct | Cardiac disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Peripheral vascular disorder | Vascular disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Diarrhea | Gastrointestinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Rectal hemorrhage | Gastrointestinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Lymphoma-like reaction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Cachexia - Death | Metabolism and nutrition disorders | COSTART 5.0 | Systematic Assessment | DEATH - Systematic and nonsystematic assessments |
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| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Arthritis | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Joint disorder | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Ovarian carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Urinary retention | Renal and urinary disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Uterine fibroids enlarged | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pain | General disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Accidental injury | Injury, poisoning and procedural complications | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Back pain | General disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Asthenia | General disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Constipation | Gastrointestinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Nausea | Gastrointestinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Vomiting | Gastrointestinal disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Dizziness | Nervous system disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Somnolence | Nervous system disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Erythema at site | Skin and subcutaneous tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
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| Pruritus at site | Skin and subcutaneous tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Rash at site | Skin and subcutaneous tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Other site reaction | Skin and subcutaneous tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Rash | Skin and subcutaneous tissue disorders | COSTART 5.0 | Systematic Assessment | Systematic and nonsystematic assessments |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Executive Medical Director | Purdue Pharma L.P. | 800-733-1333 OR 800-745-7445 |
| 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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| Title | Measurements |
|---|---|
|