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OsteoarthritisPhase 3NCT00171665

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

A Phase 3 study testing Diclofenac topical sodium gel 1% in people with Osteoarthritis, run by Novartis at 69 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Diclofenac topical sodium gel 1%
How many people
360 participants
Where
69 sitesUnited States
Study dates
May 2005to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Osteoarthritis of the hand

Who cannot join

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

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Allegheny Pain Management

    Altoona, Pennsylvania, 16602

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Radiant Research - Anderson

    Anderson, South Carolina, 29621

  • Clinsite

    Ann Arbor, Michigan, 48106

  • Heartland Research Associates, LLC

    Arkansas City, Kansas, 67005

  • Allan B. Aven, MD, SC

    Arlington Heights, Illinois, 60005

  • Radiant Research - Atlanta West

    Atlanta, Georgia, 30308

  • Walter F. Chase, MD, PA

    Austin, Texas, 78705

  • Chesapeake Medical Research, LLC

    Baltimore, Maryland, 21239

  • Neshaminy Medical, PC

    Bensalem, Pennsylvania, 19020

  • Lovelace Scientific Resources, Inc.

    Beverly Hills, California, 90211

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Intermountain Orthopaedics

    Boise, Idaho, 83702

  • Twin Cities Clinical Research

    Brooklyn Center, Minnesota, 55430

  • Medical Group @ Marple Commons

    Broomall, Pennsylvania, 19008

  • MedSearch, LLC

    Calera, Alabama, 35040

  • Med Investigations/Med Center

    Carmichael, California, 95608

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Clinical Research of CT/NY

    Danbury, Connecticut, 06810

  • Radiant Research - Minneapolis

    Edina, Minnesota, 55435

  • Westminster Family Medicine

    Erie, Pennsylvania, 16506

  • PRO Research

    Eugene, Oregon, 97401

  • Feasterville Family Health Care Center

    Feasterville, Pennsylvania, 19053

  • PrimeCare Research Associates

    Florissant, Missouri, 63031

  • Arizona Center for Clinical Research

    Glendale, Arizona, 85306

  • Allergy and Arthritis Associates

    Hamden, Connecticut, 06518

  • Arthritis & Osteoporosis Center, PC

    Hamden, Connecticut, 06518

  • Southeastern Pennsylvania Medical Institute

    Havertown, Pennsylvania, 19083

  • The Community Research of South Florida

    Hialeah, Florida, 33013

  • Unifour Medical Research Associates

    Hickory, North Carolina, 28601

  • Harmony Research, Inc.

    Johnson City, Tennessee, 37601

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Wells Institute for Heatlh Awareness

    Kettering, Ohio, 45429

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Radiant Research - Tacoma

    Lakewood, Washington, 98499

  • Miami Research Associates

    Miami, Florida, 33173

  • Advanced Healthcare, SC

    Milwaukee, Wisconsin, 53209

  • Montgomery Rheumatology Associates

    Montgomery, Alabama, 36111

  • Drug Research & Analysis Corp

    Montgomery, Alabama, 36124

  • Palmetto Medical Research

    Mt. Pleasant, South Carolina, 29464

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Health Core

    Newark, Delaware, 19713

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Dean Medical Center - Oregon Clinic

    Oregon, Wisconsin, 53575

  • Arthritis Research of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Arthritis Associates, Inc.

    Peabody, Massachusetts, 01960

  • University Clinical Research, Inc.

    Pembroke Pines, Florida, 33024

  • Andres Patron, DO PA

    Pembroke Pines, Florida, 33028

  • Clinical Research Source

    Perrysburg, Ohio, 43551

  • Radiant Research

    Philadelphia, Pennsylvania, 19115

  • Coastal Medical Research

    Port Orange, Florida, 32127

  • Crescent Medical Research

    Salisbury, North Carolina, 28144

  • Intermoutain Clinical Research

    Salt Lake City, Utah, 84102

  • Radiant Research - Salt Lake City

    Salt Lake City, Utah, 84107

  • Quality Research, Inc.

    San Antonio, Texas, 78209

  • Radiant Research - San Antonio Northeast

    San Antonio, Texas, 78217

  • Radiant Research - San Antonio

    San Antonio, Texas, 78229

  • H. Richard Barthel,MD, Inc.

    Santa Barbara, California, 93105

  • University Neurology

    Sarasota, Florida, 34243

  • Clinical Research Consultants

    Stratford, Connecticut, 06615

  • Texas Research Center, LLP

    Sugar Land, Texas, 77479

  • Southwest Florida Clinical Research Center

    Tampa, Florida, 33609

  • Quality of Life Medical Research Center, LLC

    Tucson, Arizona, 85712

  • Comprehensive Clinical Research

    Turnersville, New Jersey, 08012

  • Carolina Clinical Research

    Winston-Salem, North Carolina, 27103

  • Partners in Clinical Research

    Woonsocket, Rhode Island, 02895

  • Radiant Research - Reading

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

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

Conditions
Osteoarthritis
Being tested
Diclofenac topical sodium gel 1%
Keywords
Hand osteoarthritis, Topical NSAID, Diclofenac sodium
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac topical sodium gel 1%Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OA pain intensity in target hand at Week 4 and 6

  2. Total AUSCAN score in target hand at Week 4 and 6

  3. Global rating of disease activity by patient at Week 4 and 6

Secondary outcomes (5)

  1. OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8

  2. 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

  3. OA pain intensity in target hand and use of rescue medication recorded in diary

  4. Global evaluation of treatment at final visit

  5. Treatment responder rate according to OARSI criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
360 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00171665
Sponsor's protocol ID
VOSG-PE-315
Status last verified
Apr 2015
First submitted
13 Sep 2005
Last updated
14 Apr 2015
Results posted
No

Publications

  • 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.

    PubMed 20064249

  • 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.

    PubMed 19648310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac topical sodium gel 1% in people with Osteoarthritis, run by Novartis at 69 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OA pain intensity in target hand at Week 4 and 6. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00171665, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.

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