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

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

Tracking Information
First Received Date ^†	September 13, 2005
Last Updated Date	October 9, 2006
Start Date ^†	May 2005
Current Primary Outcome Measures ^† (submitted: May 30, 2006)	OA pain intensity in target hand at Week 4 and 6 Total AUSCAN score in target hand at Week 4 and 6 Global rating of disease activity by patient at Week 4 and 6
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00171652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: May 30, 2006)	OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 OA pain intensity in target hand 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 ^†	Same as current

Descriptive Information
Brief Title ^†	Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Official Title ^†	Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Brief Summary	This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Osteoarthritis
Intervention ^†	Drug: Diclofenac 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 ^†	Completed
Enrollment ^†	360
Completion Date	October 2005
Primary Completion Date
Eligibility Criteria ^†	Key Inclusion criteria: Osteoarthritis of the hand 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	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	France, Germany
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00171652
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Novartis
Collaborators ^††
Investigators ^†
Information Provided By	Novartis
Verification Date	October 2006
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.