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

Osteoarthritis, Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108992
• Other study ID #: PEN-03-112
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2005
• Last updated: January 4, 2007
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: January 2007
• Source: Nuvo Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac, topical

Locations

Country	Name	City	State
United States	OMC Clinical	Beverly Hills	California
United States	Associated Pharmaceutical Research	Buena Park	California
United States	Camp Hill Clinical Research Center	Camp Hill	Pennsylvania
United States	Tampa Bay Medical Research Inc.	Clearwater	Florida
United States	Research Across America	Dallas	Texas
United States	Medisphere Medical Research	Evansville	Indiana
United States	Med Investigators	Fair Oaks	California
United States	Redrock Research Center	Las Vegas	Nevada
United States	Coastal Clinical Research	Mobile	Alabama
United States	Clinical Research Associates	Nashville	Tennessee
United States	Hamptom Roads Center for Clinical Research	Norfolk	Virginia
United States	Desert Medical Advances	Palm Desert	California
United States	Redpoint Research	Phoenix	Arizona
United States	Primary Physicians Research	Pittsburgh	Pennsylvania
United States	National Clinical Research	Richmond	Virginia
United States	Synergy Medical Education Alliance	Saginaw	Michigan
United States	Sam Clinical Research Center	San Antonio	Texas
United States	University Orthopedics Center	State College	Pennsylvania
United States	Boling Clinical Trials	Upland	California
United States	Partners in Primary Care	Voorhees	New Jersey
United States	Omega Medical Research	Warwick	Rhode Island
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nuvo Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain
Primary	physical function
Primary	patient overall health assessment
Secondary	stiffness
Secondary	patient global assessment