Santa Barbara, California 93105

  • Osteoarthritis

Purpose:

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


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


Study is Available At:


Original ID:

VOSG-PE-315


NCT ID:

NCT00171665


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis


Official Title:

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

360


Enrollment Type:


Study Dates

Start Date:May 2005
Completion Date:December 2005
Verification Date:April 2015
Last Changed Date:April 13, 2015
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Treatment responder rate according to OARSI criteria
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Global evaluation of treatment at final visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:OA pain intensity in target hand and use of rescue medication recorded in diary
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Global rating of disease activity by patient at Week 4 and 6
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Total AUSCAN score in target hand at Week 4 and 6
Safety Issues:False
Outcome Type:Primary Outcome
Measure:OA pain intensity in target hand at Week 4 and 6
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Diclofenac topical sodium gel 1%

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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