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NCT00171691 Clinical Trial

Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:
Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171691
Other study ID # VOSG-PN-309
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated April 20, 2012
Start date October 2004
Est. completion date June 2006

Study information
Verified date April 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility Key Inclusion criteria

• Osteoarthritis of the knee

Key Exclusion criteria

- Other rheumatic disease, such as rheumatoid arthritis

- Active gastrointestinal ulcer during the last year

- Known allergy to analgesic drugs

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Diclofenac Topical Sodium Gel 1%

Locations
Country Name City State
United States Novartis Consumer Health Inc. Parsippany New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events
Primary Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
Secondary Incidence of serious treatment-emergent adverse events
Secondary Number of patients who discontinued study medication due to a treatment-emergent adverse event
Secondary WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12
See also
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