Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

January 4, 2007 updated by: Nuvo Research Inc.
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.

Study Type

Interventional

Enrollment

750

Phase

  • 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, 36608
        • Coastal Clinical Research
    • Arizona
      • Phoenix, Arizona, United States, 85029
        • Redpoint Research
    • California
      • Beverly Hills, California, United States, 90211
        • OMC Clinical
      • Buena Park, California, United States, 90620
        • Associated Pharmaceutical Research
      • Fair Oaks, California, United States, 95628
        • Med Investigators
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Upland, California, United States, 91786
        • Boling Clinical Trials
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research Inc.
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical Education Alliance
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Redrock Research Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Partners in Primary Care
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Camp Hill Clinical Research Center
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physicians Research
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • SAM Clinical Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23502-9921
        • Hamptom Roads Center for Clinical Research
      • Richmond, Virginia, United States, 23294
        • National Clinical Research

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

Ages Eligible for Study

36 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary osteoarthritis of the knee, verified radiographically
  • Moderate flare of pain in the knee after washout of stable therapy
  • If female, non-pregnant
  • Ability to swallow moderately-sized tablets

Exclusion Criteria:

  • Secondary osteoarthritis of the knee
  • Major knee surgery at any time, or minor knee surgery in previous year
  • Severe uncontrolled heart, liver or kidney disease
  • Ulcer or bleeding from the stomach
  • Corticosteroid use
  • Fibromyalgia
  • Skin disorder of the knee

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pain
physical function
patient overall health assessment

Secondary Outcome Measures

Outcome Measure
stiffness
patient global assessment

Collaborators and Investigators

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

Sponsor

Nuvo Research Inc.

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

February 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

April 21, 2005

First Submitted That Met QC Criteria

April 21, 2005

First Posted (Estimate)

April 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2007

Last Update Submitted That Met QC Criteria

January 4, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEN-03-112

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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