Osteoarthritis
Conditions
Keywords
Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine
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.
Interventions
DRUGBuprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity - BS (box score)-11 pain scale | 8 weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed