Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00171691
• Lead Sponsor: Novartis

Brief Summary

This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events
Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary Outcome Measures

Name	Time	Method
Incidence of serious treatment-emergent adverse events
Number of patients who discontinued study medication due to a treatment-emergent adverse event
WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

Trial Locations

Locations (1)

Novartis Consumer Health Inc.; 🇺🇸 Parsippany, New Jersey, United States