Status:
COMPLETED
Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.
Detailed Description
This randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. At screening, patients whose pain is c...
Eligibility Criteria
Inclusion
- Males or females 18 years of age or older
- Diagnosis of osteoarthritis of the knee (unilateral or bilateral)
- Meet pain entry criteria
- Willing to discontinue use of all analgesic medications (including over-the-counter \[OTC\] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.
Exclusion
- Positive urine pregnancy test, pregnant or lactating.
- Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease
- Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
- Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
- Have a history or physical examination finding that is incompatible with safe participation in the study or study product use
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
- Have significant renal or hepatic impairment
- Are taking a sleep medication at a dose that has not been stable for at least 3 months
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00365586
Start Date
August 1 2006
End Date
May 1 2007
Last Update
February 19 2020
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78704