Clinical trial NCT00171652: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Official title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Hand osteoarthritis, Topical NSAID, Diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: OA pain intensity in target hand at Week 4 and 6
measure: Total AUSCAN score in target hand at Week 4 and 6
measure: Global rating of disease activity by patient at Week 4 and 6
Secondary outcomes:
measure: OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
measure: 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
measure: OA pain intensity in target hand and use of rescue medication recorded in diary
measure: Global evaluation of treatment at final visit
measure: Treatment responder rate according to OARSI criteria
Other outcomes:
Locations:
city: Cergy
country: France
city: Clamart
country: France
city: Cournonterral
country: France
city: Fellering
country: France
city: Goussonville
country: France
city: Linas
country: France
city: Longpont sur Orge
country: France
city: Meaux
country: France
city: Nantes
country: France
city: Orly
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Savigny sur Orge
country: France
city: Thouars
country: France
city: Villeneuve le Roi
country: France
city: Bad Hersfeld
country: Germany
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dinslaken
country: Germany
city: Dortmund
country: Germany
city: Dreieich
country: Germany
city: Dresden
country: Germany
city: Frankfurt a/M
country: Germany
city: Hagen
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Karlsruhe
country: Germany
city: Kassel
country: Germany
city: Leipzig
country: Germany
city: Ludwigshafen
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Neustadt/Aisch
country: Germany
city: Nürnberg
country: Germany
city: Stuttgart
country: Germany
Study officials:
References:
citation: Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.