Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis

Launched by APR APPLIED PHARMA RESEARCH S.A. · Jul 12, 2006

Keywords

ClinConnect Summary

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients wi...

Gender

ALL

Eligibility criteria

• • Inclusion
• • Males or females 18 years of age or older
• • Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
• • Meet pain entry criteria
• • Willing to discontinue use of any pain medication not provided by the study
• Exclusion:
• • Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
• • Have received corticosteroids in the 30 days preceding screening
• • Have a history or physical examination finding that is incompatible with safe participation in the study
• • Have a history or physical examination finding that is incompatible with study product use
• • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
• • Are taking medications that may significantly affect renal function