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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014