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Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain

Osteoarthritis of the Knee Clinical Trial

Official title:
Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis

Clinical Trial Summary

This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.

Clinical Trial Description

This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00484120
Study type Interventional
Source Pharmos
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date December 2008
View Details
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