Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ibuprofen

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.