Status:
COMPLETED
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoarthritis
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE1
Brief 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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00372801
Start Date
August 1 2005
Last Update
October 16 2008
Active Locations (1)
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1
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031