Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

NCT ID: NCT00171652

Last Updated: 2006-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-10-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Hand osteoarthritis, Topical NSAID, Diclofenac sodium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Diclofenac sodium gel 1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Osteoarthritis of the hand

Exclusion Criteria

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Locations

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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

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Savigny-sur-Orge, , France

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Thouars, , France

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Villeneuve-le-Roi, , France

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Bad Hersfeld, , Germany

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Bad Nauheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Dinslaken, , Germany

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Dortmund, , Germany

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Dreieich, , Germany

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Dresden, , Germany

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Frankfurt a/M, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Karlsruhe, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Ludwigshafen, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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Neustadt/Aisch, , Germany

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Nuremberg, , Germany

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Stuttgart, , Germany

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Countries

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France Germany

References

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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.

Reference Type DERIVED
PMID: 20064249 (View on PubMed)

Other Identifiers

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VOSG-PE-314

Identifier Type: -

Identifier Source: org_study_id