Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

NCT ID: NCT00171665

Last Updated: 2015-04-14

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

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Diclofenac topical sodium gel 1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Osteoarthritis of the hand

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Locations

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Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Site Status

MedSearch, LLC

Calera, Alabama, United States

Site Status

Montgomery Rheumatology Associates

Montgomery, Alabama, United States

Site Status

Drug Research & Analysis Corp

Montgomery, Alabama, United States

Site Status

Arizona Center for Clinical Research

Glendale, Arizona, United States

Site Status

Quality of Life Medical Research Center, LLC

Tucson, Arizona, United States

Site Status

Lovelace Scientific Resources, Inc.

Beverly Hills, California, United States

Site Status

Med Investigations/Med Center

Carmichael, California, United States

Site Status

H. Richard Barthel,MD, Inc.

Santa Barbara, California, United States

Site Status

Clinical Research of CT/NY

Danbury, Connecticut, United States

Site Status

Allergy and Arthritis Associates

Hamden, Connecticut, United States

Site Status

Arthritis & Osteoporosis Center, PC

Hamden, Connecticut, United States

Site Status

Clinical Research Consultants

Stratford, Connecticut, United States

Site Status

Health Core

Newark, Delaware, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

The Community Research of South Florida

Hialeah, Florida, United States

Site Status

Health Awareness, Inc.

Jupiter, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Arthritis Research of Florida, Inc.

Palm Harbor, Florida, United States

Site Status

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

Site Status

Andres Patron, DO PA

Pembroke Pines, Florida, United States

Site Status

Coastal Medical Research

Port Orange, Florida, United States

Site Status

University Neurology

Sarasota, Florida, United States

Site Status

Southwest Florida Clinical Research Center

Tampa, Florida, United States

Site Status

Radiant Research - Atlanta West

Atlanta, Georgia, United States

Site Status

Intermountain Orthopaedics

Boise, Idaho, United States

Site Status

Allan B. Aven, MD, SC

Arlington Heights, Illinois, United States

Site Status

Heartland Research Associates, LLC

Arkansas City, Kansas, United States

Site Status

Chesapeake Medical Research, LLC

Baltimore, Maryland, United States

Site Status

Arthritis Associates, Inc.

Peabody, Massachusetts, United States

Site Status

Clinsite

Ann Arbor, Michigan, United States

Site Status

Twin Cities Clinical Research

Brooklyn Center, Minnesota, United States

Site Status

Radiant Research - Minneapolis

Edina, Minnesota, United States

Site Status

PrimeCare Research Associates

Florissant, Missouri, United States

Site Status

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Site Status

Comprehensive Clinical Research

Turnersville, New Jersey, United States

Site Status

Unifour Medical Research Associates

Hickory, North Carolina, United States

Site Status

Crescent Medical Research

Salisbury, North Carolina, United States

Site Status

Carolina Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Wells Institute for Heatlh Awareness

Kettering, Ohio, United States

Site Status

Clinical Research Source

Perrysburg, Ohio, United States

Site Status

PRO Research

Eugene, Oregon, United States

Site Status

Allegheny Pain Management

Altoona, Pennsylvania, United States

Site Status

Neshaminy Medical, PC

Bensalem, Pennsylvania, United States

Site Status

Medical Group @ Marple Commons

Broomall, Pennsylvania, United States

Site Status

Westminster Family Medicine

Erie, Pennsylvania, United States

Site Status

Feasterville Family Health Care Center

Feasterville, Pennsylvania, United States

Site Status

Southeastern Pennsylvania Medical Institute

Havertown, Pennsylvania, United States

Site Status

Radiant Research

Philadelphia, Pennsylvania, United States

Site Status

Radiant Research - Reading

Wyomissing, Pennsylvania, United States

Site Status

Partners in Clinical Research

Woonsocket, Rhode Island, United States

Site Status

Radiant Research - Anderson

Anderson, South Carolina, United States

Site Status

Palmetto Medical Research

Mt. Pleasant, South Carolina, United States

Site Status

Harmony Research, Inc.

Johnson City, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Site Status

Walter F. Chase, MD, PA

Austin, Texas, United States

Site Status

Quality Research, Inc.

San Antonio, Texas, United States

Site Status

Radiant Research - San Antonio Northeast

San Antonio, Texas, United States

Site Status

Radiant Research - San Antonio

San Antonio, Texas, United States

Site Status

Texas Research Center, LLP

Sugar Land, Texas, United States

Site Status

Intermoutain Clinical Research

Salt Lake City, Utah, United States

Site Status

Radiant Research - Salt Lake City

Salt Lake City, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Site Status

Radiant Research - Tacoma

Lakewood, Washington, United States

Site Status

Advanced Healthcare, SC

Milwaukee, Wisconsin, United States

Site Status

Dean Medical Center - Oregon Clinic

Oregon, Wisconsin, United States

Site Status

Countries

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United States

References

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Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.

Reference Type DERIVED
PMID: 20064249 (View on PubMed)

Altman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009 Sep;36(9):1991-9. doi: 10.3899/jrheum.081316. Epub 2009 Jul 31.

Reference Type DERIVED
PMID: 19648310 (View on PubMed)

Other Identifiers

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VOSG-PE-315

Identifier Type: -

Identifier Source: org_study_id

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