Clinical trial NCT00546832: Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
Official title: The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Mika Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 650
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.

Detailed description: This is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee OA) trial. The trial will enroll subjects who have been diagnosed with OA of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. Subjects who qualify to enter the study will be randomized to topical TDS-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.

Eligibility criteria: Inclusion Criteria:

* Males or females in generally good health at least 40 years of age
* Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
* Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain

Exclusion Criteria:

* Females who are pregnant or lactating or who may become pregnant
* Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
* History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)

Primary outcomes:
measure: Change from baseline in the WOMAC Composite Pain Score
timeFrame: 30 days
Secondary outcomes:
measure: Change from baseline in the WOMAC Composite Stiffness and Composite Function Scores, Change from Baseline in the Subject's Global Assessment of Arthritic Condition, Change from baseline in the Subject's Assessment of OA Pain, %OMERACT-OARSI responders
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Foothill Ranch
country: United States
state: California
city: Irvine
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: Stanford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Ococee
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Blue Ridge
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Towson
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Berlin
country: United States
state: New Jersey
city: Medford
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Bensalem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Nederland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Mika Pharma GmbH
name: Medical Affairs
role: STUDY_DIRECTOR
References: