Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis - Tabular View

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	May 29, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 29, 2006)	WOMAC pain score in target knee at Week 12 WOMAC physical function score in target knee at Week 12 Global rating of disease activity by patient at Week 12
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00171678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 29, 2006)	WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12 Pain on movement in target knee and use of rescue medication recorded in diary Global evaluation of treatment at final visit Treatment responder rate according to OARSI criteria
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official Title ^ICMJE	Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary	This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Osteearthritis
Intervention ^ICMJE	Drug: Diclofenac Topical Sodium Gel 1%
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	480
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Key Inclusion criteria OA 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
Gender	Both
Ages	35 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00171678
Responsible Party
Study ID Numbers ^ICMJE	VOSG-PN-310
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP