A Study Comparing Norspan Patch and Oral Tramadol

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg

• Registration Number: NCT01019265
• Lead Sponsor: Mundipharma Korea Ltd

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TramadolSR tab (Tridol SR tab)	Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg	-
Norspan patch (Buprenorphine TDS)	Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg	-

Primary Outcome Measures

Name	Time	Method
Pain intensity - BS (box score)-11 pain scale	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of