Clinical Trial: Efficacy and Safety of Topical Diclofenac Combined with Oral Diclofenac in the Treatment of Knee Osteoarthritis

This study is currently recruiting patients.

Sponsored by: Dimethaid Health Care
Information provided by: Dimethaid Health Care

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

Further Study Details: 
Primary Outcomes: pain; physical function; patient overall health assessment
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

Please refer to this study by ClinicalTrials.gov identifier  NCT00108992


California
      Associated Pharmaceutical Research, Buena Park,  California,  90620,  United States; Recruiting
Richard Blasco  714-952-2233 
Mercedes Samson, MD,  Principal Investigator

      Desert Medical Advances, Palm Desert,  California,  92260,  United States; Recruiting
Barbara Delph  760-341-6800 
Maria Greenwald, MD,  Principal Investigator

      OMC Clinical, Beverly Hills,  California,  90211,  United States; Recruiting
Mila Manajan  310-358-5757 
Stuart Silverman, MD,  Principal Investigator

      Boling Clinical Trials, Upland,  California,  91786,  United States; Recruiting
Carla Johnson  909-982-4252 
Eugene P. Boling, MD,  Principal Investigator

      Med Investigators, Fair Oaks,  California,  95628,  United States; Recruiting
Gaby Zumeran  916-966-7452 
Douglas Haselwood, MD,  Principal Investigator

Florida
      Tampa Bay Medical Research Inc., Clearwater,  Florida,  33761,  United States; Recruiting
Ann Tener  727-724-3316 
Steven C. Bowman, MD,  Principal Investigator

Indiana
      Medisphere Medical Research, Evansville,  Indiana,  47714,  United States; Recruiting
Melinda Swanker  812-471-4110 
Steven K. Elliot, MD,  Principal Investigator

Michigan
      Synergy Medical Education Alliance, Saginaw,  Michigan,  48602,  United States; Recruiting
Dianne Androsuk  989-583-6936 
Rebecca Baumbach, MD,  Principal Investigator

Nevada
      Redrock Research Center, Las Vegas,  Nevada,  89146,  United States; Recruiting
Tracy Dodson  702-942-3200 
Rachakonda Prabhu, MD,  Principal Investigator

New Jersey
      Partners in Primary Care, Voorhees,  New Jersey,  08043,  United States; Recruiting
Maria Kassal  856-741-0129 
Ralph Costa, MD,  Principal Investigator

Pennsylvania
      Primary Physicians Research, Pittsburgh,  Pennsylvania,  15241,  United States; Recruiting
Melanie Isralsky  412-257-4461 
Keith Reisinger, MD,  Principal Investigator

      University Orthopedics Center, State College,  Pennsylvania,  16801,  United States; Recruiting
Sue Jepson  814-231-2101 
James S. Martin, MD,  Principal Investigator

      Camp Hill Clinical Research Center, Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
Nancy Lee  717-763-9311 
Rodney Lynn Magargle, MD,  Principal Investigator

Rhode Island
      Omega Medical Research, Warwick,  Rhode Island,  02886,  United States; Recruiting
Joy Geer  401-739-9350 
David Fried, MD,  Principal Investigator

Tennessee
      Clinical Research Associates, Nashville,  Tennessee,  37203,  United States; Recruiting
Sandra Shwab  615-329-0197 
Stephan C. Sharp, MD,  Principal Investigator

Texas
      Sam Clinical Research Center, San Antonio,  Texas,  78229,  United States; Recruiting
Caroline Keith  210-614-4800 
Sam S. Miller, MD,  Principal Investigator

      Research Across America, Dallas,  Texas,  75234,  United States; Recruiting
Tony Bondora  972-241-1222 
Julius Wolfram, MD,  Principal Investigator

More Information

Study ID Numbers:  PEN-03-112
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