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

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Diclofenac, topical (Drug)

Phase: Phase 3

Status: Completed

Sponsored 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

pain

physical function

patient overall health assessment

Secondary outcome:

stiffness

patient global assessment

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.

Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): 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

Coastal Clinical Research, Mobile, Alabama 36608, United States

Redpoint Research, Phoenix, Arizona 85029, United States

Associated Pharmaceutical Research, Buena Park, California 90620, United States

Desert Medical Advances, Palm Desert, California 92260, United States

OMC Clinical, Beverly Hills, California 90211, United States

Boling Clinical Trials, Upland, California 91786, United States

Med Investigators, Fair Oaks, California 95628, United States

Tampa Bay Medical Research Inc., Clearwater, Florida 33761, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Medisphere Medical Research, Evansville, Indiana 47714, United States

Synergy Medical Education Alliance, Saginaw, Michigan 48602, United States

Redrock Research Center, Las Vegas, Nevada 89146, United States

Partners in Primary Care, Voorhees, New Jersey 08043, United States

Primary Physicians Research, Pittsburgh, Pennsylvania 15241, United States

University Orthopedics Center, State College, Pennsylvania 16801, United States

Camp Hill Clinical Research Center, Camp Hill, Pennsylvania 17011, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Clinical Research Associates, Nashville, Tennessee 37203, United States

Sam Clinical Research Center, San Antonio, Texas 78229, United States

Research Across America, Dallas, Texas 75234, United States

Hamptom Roads Center for Clinical Research, Norfolk, Virginia 23502-9921, United States

National Clinical Research, Richmond, Virginia 23294, United States

Starting date: February 2004
Ending date: September 2005
Last updated: January 4, 2007