Back to resultsA Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Transdermal delivery system
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
Eligibility Criteria
Inclusion Criteria:
- OA diagnosis
- BS11 greater than or equal to 4 at base line
- Not adequately pain relieved with 4,000 mg paracetamol daily
Exclusion Criteria:
- Treated with high potent opioids for their OA pain
- Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
- Other chronic conditions requiring frequent analgesic therapy
Sites / Locations
- Dr Mats Karlsson
Outcomes
Primary Outcome Measures
Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
Secondary Outcome Measures
Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00399178
Brief Title
A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
Official Title
A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mundipharma AB
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Transdermal delivery system
Primary Outcome Measure Information:
Title
Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
Secondary Outcome Measure Information:
Title
Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
OA diagnosis
BS11 greater than or equal to 4 at base line
Not adequately pain relieved with 4,000 mg paracetamol daily
Exclusion Criteria:
Treated with high potent opioids for their OA pain
Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
Other chronic conditions requiring frequent analgesic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Karlsson, Med
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Mats Karlsson
City
Falkoping
State/Province
Parkgatan 6C
ZIP/Postal Code
521 43
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
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