Clinical trial NCT01019265: A Study Comparing Norspan Patch and Oral Tramadol
Official title: A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Norspan patch
Buprenorphine transdermal patch (BTDS)
efficacy
buprenorphine
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain intensity - BS (box score)-11 pain scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 8 weeks
measure: Degree of sleep disturbance due to pain and improvement in quality of sleep
timeFrame: 8 weeks
measure: Incidence of early discontinuation due to lack of efficacy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myun Chul Lee
role: PRINCIPAL_INVESTIGATOR
References: