A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

  • STATUS
    Not Recruiting
  • participants needed
    1212
  • sponsor
    Mylan Inc.
Updated on 25 April 2021
osteoarthritis
moderate pain

Summary

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of steoarthritis of knee compared to Voltaren gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.

Male or non-pregnant female aged 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria

Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.

Details
Condition Osteoarthritis of knee
Treatment Placebo gel, Diclofenac sodium gel 1%, Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Clinical Study IdentifierNCT03172780
SponsorMylan Inc.
Last Modified on25 April 2021

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