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

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Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.

Study NCT00171678. Last updated on May 29, 2006. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	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
Secondary Outcome Measure ^†	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
Condition ^†	Osteearthritis
Intervention ^†	Drug: Diclofenac Topical Sodium Gel 1%
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	480
Start Date ^†
Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00171678
Organization ID	VOSG-PN-310
Secondary IDs ^††
Study Sponsor ^†	Novartis
Collaborators ^††
Investigators ^†
Information Provided By	Novartis
Verification Date	May 2006
First Received Date ^†	September 13, 2005
Last Updated Date	May 29, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.