Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

October 9, 2006 updated by: Novartis
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cergy, France, 95000
      • Clamart, France, 92140
      • Cournonterral, France, 34660
      • Fellering, France, 68470
      • Goussonville, France, 78930
      • Linas, France, 91310
      • Longpont sur Orge, France, 91310
      • Meaux, France, 77100
      • Nantes, France, 44000
      • Orly, France, 94310
      • Paris, France, 75015
      • Paris, France, 75010
      • Paris, France, 75020
      • Paris, France, 75011
      • Savigny sur Orge, France, 91600
      • Thouars, France, 79100
      • Villeneuve le Roi, France, 94290
  • Germany
      • Bad Hersfeld, Germany, 36251
      • Bad Nauheim, Germany, 61231
      • Berlin, Germany, 13125
      • Berlin, Germany, 10589
      • Berlin, Germany, 10711
      • Berlin, Germany, 10961
      • Berlin, Germany, 12247
      • Berlin, Germany, 13581
      • Berlin, Germany, 14163
      • Bochum, Germany, 44789
      • Dinslaken, Germany, 46535
      • Dortmund, Germany, 44263
      • Dreieich, Germany, 63303
      • Dresden, Germany, 01129
      • Frankfurt a/M, Germany, 60433
      • Hagen, Germany, 58099
      • Hamburg, Germany, 20249
      • Hamburg, Germany, 22143
      • Hamburg, Germany, 20357
      • Hamburg, Germany, 22767
      • Karlsruhe, Germany, 76133
      • Kassel, Germany, 34123
      • Leipzig, Germany, 04109
      • Ludwigshafen, Germany, 67069
      • München, Germany, 80333
      • München, Germany, 80339
      • München, Germany, 80538
      • München, Germany, 80798
      • Neustadt/Aisch, Germany, 91413
      • Nürnberg, Germany, 90441
      • Stuttgart, Germany, 70178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
Global evaluation of treatment at final visit
Treatment responder rate according to OARSI criteria
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 9, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOSG-PE-314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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