NCT00484120

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Pharmos · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	3%-Diclofenac-Nano-Emulsion Cream	3%-Diclofenac-Nano-Emulsion Cream
DRUG	Placebo cream	Placebo cream

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2007-06-08
• Last updated: 2011-08-02

Locations

4 sites across 1 country: Israel