Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

December 13, 2007 updated by: Novartis

A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 33608
        • Coastal Clinical Research Inc
      • Tallassee, Alabama, United States, 36078
        • River Region Research, LLC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Family Physicians
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
    • Arkansas
      • Arkansas City, Arkansas, United States, 67005
        • Heartland Research Associates LLC
    • California
      • Beverly Hills, California, United States, 92011
        • Lovelace Scientific Research, Inc.
      • Carmichael, California, United States, 95608
        • MED Investigations
      • Fair Oaks, California, United States, 95628
        • Med Investigations, Inc.
      • Fresno, California, United States, 93703
        • Universal BioPharma Research, Inc.
      • Santa Barbara, California, United States, 93108
        • Santa Barbara Clinical Research, Inc
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
    • Connecticut
      • Stratford, Connecticut, United States, 06615
        • Clinical Research Consultants, LLC
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Seidman Clinical Trials
      • Gainesville, Florida, United States, 32607
        • Florida Medical Research Institute
      • Hollywood, Florida, United States, 33023
        • South Florida Clinical Research Center
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Largo, Florida, United States, 33774
        • Suncoast Internal Medicine Consultants
      • Miami, Florida, United States, 33155
        • AppleMed Research, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Opa Locka, Florida, United States, 33056
        • Sunshine Research Center, LLC
      • Ormond Beach, Florida, United States, 32174
        • Peninsula Research, Inc.
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Pembroke Pines, Florida, United States, 33028
        • Andres Patron DO PA
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research - St Petersburg
      • Plantation, Florida, United States, 33324
        • Sunrise Medical Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • Stuart, Florida, United States, 34996
        • Radiant Research
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Orthopaedics
    • Indiana
      • Munster, Indiana, United States, 46321
        • Medical Specialists Clinical Research Center
    • Kansas
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Best Clinical Trial, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Peter A. Holt, MD
      • Wheaton, Maryland, United States, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase III Clinical Research
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research, Inc
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Internal Medical Associates
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • South Jersey Medical Associates, PA
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • North Carolina Arthritis & Allergy Care Center
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc
      • Columbus, Ohio, United States, 43212
        • Radiant Research
      • Mogadore, Ohio, United States, 44260
        • Radiant Research, Inc. - Akron
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Neshaminy Medical, PC
      • Erie, Pennsylvania, United States, 16506
        • Westminster Family Medicine
      • Feasterville, Pennsylvania, United States, 19053
        • Feasterville Family Health Care Center
      • Havertown, Pennsylvania, United States, 19083
        • Southeastern Pennsylvania Medical Institute
      • Philadelphia, Pennsylvania, United States, 19115
        • Radiant Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research - Anderson
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Austin, Texas, United States, 78705
        • Walter F. Chase, M.D., P.A.
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas North
      • San Antonio, Texas, United States, 78209
        • Quality Research, Inc.
      • San Antonio, Texas, United States, 78229
        • Radiant Research - San Antonio
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center, LLP
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
      • Virginia Beach, Virginia, United States, 23451
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • The Physicians Clinic of Spokane
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
Placebo Comparator: 2
Drug: Placebo
4 grams per knee, 4 times per day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roy Altman, MD, University of California, in Los Angeles, Division of Rheumatology, 310 206 7866

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VOSG-PN-316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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