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NCT Number: NCT01019265

A 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 (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg

Drug

Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

Other names: Norspan patch, Buprenorphine transdermal system (BTDS)

Primary outcomes

  1. Pain intensity - BS (box score)-11 pain scale

    Time frame: 8 weeks

Secondary outcomes

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 8 weeks

  2. Degree of sleep disturbance due to pain and improvement in quality of sleep

    Time frame: 8 weeks

  3. Incidence of early discontinuation due to lack of efficacy

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study title

A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2009
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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