Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Phase 3CompletedNCT00171652

Novartis360 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

360

Conditions

Osteoarthritis

Interventions

Diclofenac sodium gel 1%DRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (48)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Unnamed facility

Cergy, France

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Clamart, France

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Cournonterral, France

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Fellering, France

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Goussonville, France

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Linas, France

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Longpont-sur-Orge, France

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Meaux, France

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Nantes, France

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Orly, France

...and 38 more locations