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

NCT ID: NCT00108992

Last Updated: 2007-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-09-30

Brief Summary

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Diclofenac, topical

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvo Research Inc.

INDUSTRY

Sponsor Role: lead

Locations

Coastal Clinical Research

Mobile, Alabama, United States

Redpoint Research

Phoenix, Arizona, United States

OMC Clinical

Beverly Hills, California, United States

Associated Pharmaceutical Research

Buena Park, California, United States

Med Investigators

Fair Oaks, California, United States

Desert Medical Advances

Palm Desert, California, United States

Boling Clinical Trials

Upland, California, United States

Tampa Bay Medical Research Inc.

Clearwater, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Medisphere Medical Research

Evansville, Indiana, United States

Synergy Medical Education Alliance

Saginaw, Michigan, United States

Redrock Research Center

Las Vegas, Nevada, United States

Partners in Primary Care

Voorhees Township, New Jersey, United States

Camp Hill Clinical Research Center

Camp Hill, Pennsylvania, United States

Primary Physicians Research

Pittsburgh, Pennsylvania, United States

University Orthopedics Center

State College, Pennsylvania, United States

Omega Medical Research

Warwick, Rhode Island, United States

Clinical Research Associates

Nashville, Tennessee, United States

Research Across America

Dallas, Texas, United States

Sam Clinical Research Center

San Antonio, Texas, United States

Hamptom Roads Center for Clinical Research

Norfolk, Virginia, United States

National Clinical Research

Richmond, Virginia, United States

Countries

United States

Other Identifiers

PEN-03-112

Identifier Type: -

Identifier Source: org_study_id