A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
Overview
- Phase
- Phase 4
- Intervention
- Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
- Conditions
- Osteoarthritis
- Sponsor
- Mundipharma Korea Ltd
- Enrollment
- 170
- Locations
- 5
- Primary Endpoint
- Pain intensity - BS (box score)-11 pain scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Norspan patch (Buprenorphine TDS)
Intervention: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
TramadolSR tab (Tridol SR tab)
Intervention: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Outcomes
Primary Outcomes
Pain intensity - BS (box score)-11 pain scale
Time Frame: 8 weeks
Secondary Outcomes
- Incidence of early discontinuation due to lack of efficacy(8 weeks)
- 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)