Not Signed In -
Diclofenac Potassium |
Cataflam |
Clinical Trial: Efficacy and Safety of Topical Diclofenac Combined with Oral Diclofenac in the Treatment of Knee Osteoarthritis
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Osteoarthritis, Knee | Drug: Diclofenac, topical | Phase III |
MedlinePlus related topics: Osteoarthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Secondary Outcomes: stiffness; patient global assessment
Expected Total Enrollment: 750
Study start: February 2004
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.
Eligibility
Ages Eligible for Study: 40 Years - 85 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
California
Associated Pharmaceutical Research, Buena Park, California, 90620, United States; Recruiting
Mercedes Samson, MD, Principal Investigator
Desert Medical Advances, Palm Desert, California, 92260, United States; Recruiting
Maria Greenwald, MD, Principal Investigator
OMC Clinical, Beverly Hills, California, 90211, United States; Recruiting
Stuart Silverman, MD, Principal Investigator
Boling Clinical Trials, Upland, California, 91786, United States; Recruiting
Eugene P. Boling, MD, Principal Investigator
Med Investigators, Fair Oaks, California, 95628, United States; Recruiting
Douglas Haselwood, MD, Principal Investigator
Florida
Tampa Bay Medical Research Inc., Clearwater, Florida, 33761, United States; Recruiting
Steven C. Bowman, MD, Principal Investigator
Indiana
Medisphere Medical Research, Evansville, Indiana, 47714, United States; Recruiting
Steven K. Elliot, MD, Principal Investigator
Michigan
Synergy Medical Education Alliance, Saginaw, Michigan, 48602, United States; Recruiting
Rebecca Baumbach, MD, Principal Investigator
Nevada
Redrock Research Center, Las Vegas, Nevada, 89146, United States; Recruiting
Rachakonda Prabhu, MD, Principal Investigator
New Jersey
Partners in Primary Care, Voorhees, New Jersey, 08043, United States; Recruiting
Ralph Costa, MD, Principal Investigator
Pennsylvania
Primary Physicians Research, Pittsburgh, Pennsylvania, 15241, United States; Recruiting
Keith Reisinger, MD, Principal Investigator
University Orthopedics Center, State College, Pennsylvania, 16801, United States; Recruiting
James S. Martin, MD, Principal Investigator
Camp Hill Clinical Research Center, Camp Hill, Pennsylvania, 17011, United States; Recruiting
Rodney Lynn Magargle, MD, Principal Investigator
Rhode Island
Omega Medical Research, Warwick, Rhode Island, 02886, United States; Recruiting
David Fried, MD, Principal Investigator
Tennessee
Clinical Research Associates, Nashville, Tennessee, 37203, United States; Recruiting
Stephan C. Sharp, MD, Principal Investigator
Texas
Sam Clinical Research Center, San Antonio, Texas, 78229, United States; Recruiting
Sam S. Miller, MD, Principal Investigator
Research Across America, Dallas, Texas, 75234, United States; Recruiting
Julius Wolfram, MD, Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 21, 2005
Record first received: April 21, 2005
ClinicalTrials.gov Identifier: NCT00108992
Health Authority: Canada: Health Canada (Awaiting confirmation); United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- Cataflam (Drug Digest)
- Diclofenac Potassium (Drug Digest)
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