A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
Information source: Mundipharma AB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Transdermal delivery system (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mundipharma AB Official(s) and/or principal investigator(s):
M Karlsson, Med, Principal Investigator, Affiliation: Unaffiliated
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dr Mats Karlsson, Falkoping, Parkgatan 6C 521 43, Sweden
Additional Information
Starting date: November 2006
Ending date: June 2007
Last updated: August 16, 2007
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