Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Condition(s) targeted: Osteoarthritis

Intervention: Diclofenac sodium gel 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

Official title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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

Secondary outcome:

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Cournonterral 34660, France

Nantes 44000, France

Fellering 68470, France

Paris 75010, France

Paris 75011, France

Paris 75015, France

Paris 75020, France

Meaux 77100, France

Goussonville 78930, France

Thouars 79100, France

Longpont sur Orge 91310, France

Linas 91310, France

Savigny sur Orge 91600, France

Clamart 92140, France

Villeneuve le Roi 94290, France

Orly 94310, France

Cergy 95000, France

Dresden 01129, Germany

Leipzig 04109, Germany

Berlin 10589, Germany

Berlin 10711, Germany

Berlin 10961, Germany

Berlin 12247, Germany

Berlin 13125, Germany

Berlin 13581, Germany

Berlin 14163, Germany

Hamburg 20249, Germany

Hamburg 20357, Germany

Hamburg 22143, Germany

Hamburg 22767, Germany

Kassel 34123, Germany

Bad Hersfeld 36251, Germany

Dortmund 44263, Germany

Bochum 44789, Germany

Dinslaken 46535, Germany

Hagen 58099, Germany

Frankfurt a/M 60433, Germany

Bad Nauheim 61231, Germany

Dreieich 63303, Germany

Ludwigshafen 67069, Germany

Stuttgart 70178, Germany

Karlsruhe 76133, Germany

München 80333, Germany

München 80339, Germany

München 80538, Germany

München 80798, Germany

Nürnberg 90441, Germany

Neustadt/Aisch 91413, Germany

Starting date: May 2005
Ending date: October 2005
Last updated: October 9, 2006