A Study Comparing Norspan Patch and Oral Tramadol
A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
1 other identifier
interventional
170
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedJuly 8, 2015
July 1, 2015
1 year
November 24, 2009
July 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity - BS (box score)-11 pain scale
8 weeks
Secondary Outcomes (3)
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
Study Arms (2)
Norspan patch (Buprenorphine TDS)
EXPERIMENTALTramadolSR tab (Tridol SR tab)
ACTIVE COMPARATORInterventions
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Asan Medical Center
Seoul, South Korea
Hanyang University Medical Center
Seoul, South Korea
National Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myun Chul Lee
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
March 1, 2008
Primary Completion
March 1, 2009
Study Completion
May 1, 2009
Last Updated
July 8, 2015
Record last verified: 2015-07