Back to resultsA Study Comparing Norspan Patch and Oral Tramadol
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis focused on measuring Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine
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.
Sites / Locations
- Asan Medical Center
- Hanyang University Medical Center
- National Medical Center
- Samsung Medical Center
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Norspan patch (Buprenorphine TDS)
TramadolSR tab (Tridol SR tab)
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity - BS (box score)-11 pain scale
Secondary Outcome Measures
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Degree of sleep disturbance due to pain and improvement in quality of sleep
Incidence of early discontinuation due to lack of efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01019265
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norspan patch (Buprenorphine TDS)
Arm Type
Experimental
Arm Title
TramadolSR tab (Tridol SR tab)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Other Intervention Name(s)
Norspan patch, Buprenorphine transdermal system (BTDS)
Intervention Description
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
Primary Outcome Measure Information:
Title
Pain intensity - BS (box score)-11 pain scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
8 weeks
Title
Degree of sleep disturbance due to pain and improvement in quality of sleep
Time Frame
8 weeks
Title
Incidence of early discontinuation due to lack of efficacy
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myun Chul Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
National Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Norspan Patch and Oral Tramadol
We'll reach out to this number within 24 hrs