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Completed
NCT00365586
Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee
Conditions: Osteoarthritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Alkemira SA
Location: PPD Austin Texas
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT00365586). StuddyBuddy aggregates publicly available trial information.