A Study Comparing Norspan Patch and Oral Tramadol

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

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 tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

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 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.

Intervention(s) in this Clinical Trial

• Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
  • Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Norspan patch (Buprenorphine TDS)
• Active Comparator: TramadolSR tab (Tridol SR tab)

Primary Measures

• Pain intensity - BS-11 pain scale
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• WOMAC score
  • Time Frame: 8 weeks
    Safety Issue?: No
• Degree of sleep disturbance due to pain and improvement in quality of sleep
  • Time Frame: 8 weeks
    Safety Issue?: No
• Incidence of early discontinuation due to lack of efficacy
  • Time Frame: 8 weeks
    Safety Issue?: 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 NSAID transdermal preparation less than 2 weeks prior to the screening visit.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Mundipharma Industry

Overall Clinical Trial Officials and Contacts

Myun Chul Lee Principal Investigator Seoul National University Hospital  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019265

Study ID Number: BUP07-KR-001

ClinicalTrials.gov Identifier: NCT01019265

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)