Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

NCT ID: NCT00171691

Last Updated: 2012-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-06-30

Brief Summary

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This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Diclofenac Topical Sodium Gel 1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Osteoarthritis of the knee

Exclusion Criteria

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Consumer Health Inc.

Parsippany, New Jersey, United States

Site Status

Countries

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United States

References

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Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918.

Reference Type DERIVED
PMID: 22030938 (View on PubMed)

Other Identifiers

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VOSG-PN-309

Identifier Type: -

Identifier Source: org_study_id

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