Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
1 other identifier
interventional
360
2 countries
48
Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2005
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedOctober 11, 2006
October 1, 2006
September 13, 2005
October 9, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the hand
You may not qualify if:
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (48)
Unknown Facility
Cergy, 95000, France
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Clamart, 92140, France
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Cournonterral, 34660, France
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Fellering, 68470, France
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Goussonville, 78930, France
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Linas, 91310, France
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Longpont-sur-Orge, 91310, France
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Meaux, 77100, France
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Nantes, 44000, France
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Orly, 94310, France
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Paris, 75010, France
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Paris, 75011, France
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Paris, 75015, France
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Paris, 75020, France
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Savigny-sur-Orge, 91600, France
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Thouars, 79100, France
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Villeneuve-le-Roi, 94290, France
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Bad Hersfeld, 36251, Germany
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Bad Nauheim, 61231, Germany
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Berlin, 10589, Germany
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Berlin, 10711, Germany
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Berlin, 10961, Germany
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Berlin, 12247, Germany
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Berlin, 13125, Germany
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Berlin, 13581, Germany
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Berlin, 14163, Germany
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Bochum, 44789, Germany
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Dinslaken, 46535, Germany
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Dortmund, 44263, Germany
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Dreieich, 63303, Germany
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Dresden, 01129, Germany
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Frankfurt a/M, 60433, Germany
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Hagen, 58099, Germany
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Hamburg, 20249, Germany
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Hamburg, 20357, Germany
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Hamburg, 22143, Germany
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Hamburg, 22767, Germany
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Karlsruhe, 76133, Germany
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Kassel, 34123, Germany
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Leipzig, 04109, Germany
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Ludwigshafen, 67069, Germany
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München, 80333, Germany
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München, 80339, Germany
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München, 80538, Germany
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München, 80798, Germany
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Neustadt/Aisch, 91413, Germany
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Nuremberg, 90441, Germany
Unknown Facility
Stuttgart, 70178, Germany
Related Publications (1)
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.
PMID: 20064249DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Study Completion
October 1, 2005
Last Updated
October 11, 2006
Record last verified: 2006-10