A Study Comparing Norspan Patch and Oral Tramadol

Study Overview
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Brief Summary
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This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

Detailed Description
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The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR (slow release) Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.

Official Title
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A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged more than 18 years. Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint. Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics. Exclusion Criteria: Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain. Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit. Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norspan patch (Buprenorphine TDS)<br> | Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg<br>* Comparing pain intensity between intervention drugs (Norspan® and Tridol®)<br>* Other names: Buprenorphine transdermal system (BTDS);|
| Active Comparator: TramadolSR tab (Tridol SR tab)<br> | Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg<br>* Comparing pain intensity between intervention drugs (Norspan® and Tridol®)<br>* Other names: Buprenorphine transdermal system (BTDS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity - BS (box score)-11 pain scale |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) |  | 8 weeks | 
| Degree of sleep disturbance due to pain and improvement in quality of sleep |  | 8 weeks | 
| Incidence of early discontinuation due to lack of efficacy |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine