Expired Study
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Parsippany, New Jersey


Purpose:

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


Criteria:

Key Inclusion criteria - Osteoarthritis of the knee 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-PN-304


NCT ID:

NCT00171626


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis


Official Title:

Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

35 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, Intervention Model: Para


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

480


Enrollment Type:


Study Dates

Start Date:August 2004
Completion Date:June 2005
Completion Type:Actual
Primary Completion Date:June 2005
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 20, 2012
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:WOMAC pain score in target knee at Week 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:WOMAC physical function score in target knee at Week 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Global rating of disease activity by patient at Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain on movement in target knee and use of rescue medication recorded in diary
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Global evaluation of treatment at final visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Treatment responder rate according to OARSI criteria
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: November 18, 2019

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