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The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
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 |
|---|---|---|---|
| BTDS10/20 | Experimental | Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. |
|
| BTDS 20 | Experimental | Initial doses (Level 1) of BTDS 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 |
|---|---|---|
| The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period). | 14 days |
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Inclusion Criteria:
- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Drug Research | Birmingham | Alabama | 35007 | United States | ||
| Redpoint Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22409388 | Result | Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12. |
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N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily "average pain over the last 24 hours" score of 0=none or 1=mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
Study dates: 26-Jun-2003 (first patient first visit) to 21-Jul-2004 (last patient last visit) in 29 medical/research centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind BTDS 10/20 | Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Phoenix |
| Arizona |
| 85029 |
| United States |
| Advanced Clinical Therapeutics | Tucson | Arizona | 85712 | United States |
| Tucson Orthopedic Institute | Tucson | Arizona | 85712 | United States |
| Hot Springs Mercy Pain Clinic | Hot Springs | Arkansas | 71913 | United States |
| Private Practice | Pine Bluff | Arkansas | 71603 | United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Lovelace Scientific Resources | Beverly Hills | California | 90211 | United States |
| Southbay Pharma Research | Buena Park | California | 90620 | United States |
| Community Medical Providers | Clovis | California | 93611 | United States |
| Kaiser Permanente | Escondido | California | 92025 | United States |
| Univ. of Southern California | Santa Monica | California | 90404 | United States |
| Arthritis Center of CT | Waterbury | Connecticut | 06708 | United States |
| Lifespan Research Foundation, Inc. | Miami | Florida | 33186 | United States |
| Miami Beach Anesthesiology Associates | Miami Beach | Florida | 33140 | United States |
| Neuro Science and Spine Assoc. | Naples | Florida | 34102 | United States |
| West Broward Rheumatology Association, Inc. | Tamarac | Florida | 33321 | United States |
| Intermountain Orthopaedics | Boise | Idaho | 83702 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Bluegrass Orthopaedics | Lexington | Kentucky | 40509 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Dolby Providers, Inc. | New Orleans | Louisiana | 70128 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Westside Family Medical Center | Kalamazoo | Michigan | 49009 | United States |
| PCM Medical Services | Lansing | Michigan | 48917 | United States |
| HealthCare Research LLC | St Louis | Missouri | 63141 | United States |
| Northeast Pain Research Center | Barrington | New Hampshire | 03825 | United States |
| The Arthritis Clinic and Carolina Bone and Joint | Charlotte | North Carolina | 28210 | United States |
| Dayton Primary and Urgent Care | Dayton | Ohio | 45402 | United States |
| The Medford Medical Clinic | Medford | Oregon | 97504 | United States |
| The Arthritis and Osteoporosis Center | Orangeburg | South Carolina | 29118 | United States |
| CEDRA Clinical Research, | Austin | Texas | 78759 | United States |
| Renaissance Clinical Research & Hypertension Clinic | Dallas | Texas | 75235 | United States |
| Spine Care Southwest. | Houston | Texas | 77074 | United States |
| KRK Medical Research | Richardson | Texas | 75080 | United States |
| Monroe Medical Foundation | Monroe | Wisconsin | 53566 | United States |
| Double-blind BTDS 20 |
Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind BTDS 10/20 | Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. |
| BG001 | Double-blind BTDS 20 | Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. |
| 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 |
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| 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 Percentage of Subjects Who Completed the 14-day Double-blind Phase. | The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period). | Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 14 days |
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Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and followed until resolution or 30 days after the last dose of study drug, or discontinuation; serious AEs were followed until the AE stabilized
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 BTDS 10/20 | Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. | 2 | 101 | 31 | 101 | ||
| EG001 | Double-blind BTDS 20 | Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. | 3 | 103 | 47 | 103 | ||
| EG002 | Open-label Run-in Period - Vicodin | N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily "average pain over the last 24 hours" score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in. | 0 | 266 | 15 | 266 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Creutzfeldt-Jacob disease - DEATH | Infections and infestations | MedDRA (5.1) | Systematic Assessment | DEATH Systematic and nonsystematic assessments |
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| Exacerbation of anxiety disorder | Psychiatric disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Increased hypertension | Vascular disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Rash NOS, Chest, Arms, Face | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | 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 |
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| Overall |
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