Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Ibuprofen (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, BSc(Hons) MB BS PhD FRACP, Study Director, Affiliation: GlaxoSmithKline
Summary
To demonstrate that new drugs work, many complex multidose studies are often required. The
intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to
validate a simpler single dose model for future assessment of new pain drugs.
Clinical Details
Official title: A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
Secondary outcome: Responder rate
Patient impression of change - 8 & 24 hrs post dose
Time to use of rescue medication (paracetamol)
Eligibility
Minimum age: N/A.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Subjects diagnosed with primary Osteoarthritis of the knee.
- Have at least 3 months in symptom duration prior to screening visit.
- Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective
cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
- Pain walking on flat surface within specific interval prior to study start.
Exclusion criteria:
- History of hypersensitivity to NSAIDS.
- Allergy to Ibuprofen.
- Use of assistive devices other than a cane or knee brace.
- History of specified diseases/illnesses.
- Abnormal blood tests pre-study.
Locations and Contacts
GSK Clinical Trials Call Centre, Sydney, New South Wales 2031, Australia
Additional Information
Starting date: July 2005
Last updated: April 16, 2007
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