Clinical trial NCT00108992: Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: topical NSAID
topical diclofenac
Lead sponsor: Nuvo Research Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-22
Enrollment: 750
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain
measure: physical function
measure: patient overall health assessment
Secondary outcomes:
measure: stiffness
measure: patient global assessment
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Beverly Hills
country: United States
facility: OMC Clinical
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research
state: California
city: Fair Oaks
country: United States
facility: Med Investigators
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Evansville
country: United States
facility: Medisphere Medical Research
state: Indiana
city: Saginaw
country: United States
facility: Synergy Medical Education Alliance
state: Michigan
city: Las Vegas
country: United States
facility: Redrock Research Center
state: Nevada
city: Voorhees
country: United States
facility: Partners in Primary Care
state: New Jersey
city: Camp Hill
country: United States
facility: Camp Hill Clinical Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Sam Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Hamptom Roads Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
Study officials:
References: