Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171652
First received: September 13, 2005
Last updated: October 9, 2006
Last verified: October 2006
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: Diclofenac sodium gel 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 360
Study Start Date: May 2005
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171652

  Show 48 Study Locations
Sponsors and Collaborators
Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00171652     History of Changes
Other Study ID Numbers: VOSG-PE-314
Study First Received: September 13, 2005
Last Updated: October 9, 2006
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Hand osteoarthritis, Topical NSAID, Diclofenac sodium

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014