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| ID | Type | Description | Link |
|---|---|---|---|
| BUP4004 |
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The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| buprenorphine transdermal system | Experimental | Buprenorphine transdermal 7 day analgesic patch |
|
| codeine paracetamol tablets | Active Comparator | codeine paracetamol combination tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | buprenorphine transdermal system 5, 10 and 20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Pain Scores - BS11 Pain Scores. | The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. | every day over a 12 week study duration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Philip Conaghan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Napp Pharmaceuticals Ltd | Cambridge | CB4 0GW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21477658 | Derived | Conaghan PG, O'Brien CM, Wilson M, Schofield JP. Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6. |
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Screening for patient eligibility
Primary care. March 2006 to Aug 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine Transdermal System | Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days |
| FG001 | Co-codamol Tablets | combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine Transdermal System | Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days |
| BG001 | Co-codamol Tablets | combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Subjects over 60 years of age were recruited into the study. Initially study started with recruitment age of 65 but this was lowered by protocol amendment to 60 years of age. |
| 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 | Average Daily Pain Scores - BS11 Pain Scores. | The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. | Posted | Mean | Standard Deviation | Box Scale 11 boxes | every day over a 12 week study duration. |
|
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Serious and non serious adverse events were collected/assessed but not serious adverse events
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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 | Buprenorphine Transdermal System | Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Schofield, Medical Director | Napp Pharmaceutical Ltd | 01223424444 | info@contact-clinical-trials.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| C526278 | acetaminophen, codeine drug combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Codeine paracetamol | Drug | combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 |
|
|
| Lost to Follow-up |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Co-codamol Tablets | combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |