Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I

Condition(s) targeted: Osteoarthritis

Intervention: TDS-943 (topical diclofenac sodium 4% spray) (Drug); celecoxib (Drug); placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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.

Official title: The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline in the WOMAC Composite Pain Score

Secondary outcome: 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

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.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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)

Trial Manager, Email: clintrialparticipation@wyeth.com

Mobile, Alabama 36608, United States; Recruiting

Huntsville, Alabama 35801, United States; Terminated

Tucson, Arizona 85741, United States; Recruiting

Tucson, Arizona 85710, United States; Terminated

Mesa, Arizona 85206, United States; Recruiting

Santa Barbara, California 93108, United States; Recruiting

Fair Oaks, California 95628, United States; Recruiting

Pico Rivera, California 90660, United States; Recruiting

Torrance, California 90505, United States; Recruiting

Ocala, Florida 34474, United States; Recruiting

DeLand, Florida 32720, United States; Recruiting

Kissimmee, Florida 34741, United States; Recruiting

Stuart, Florida 34996, United States; Recruiting

Pembroke Pines, Florida 33024, United States; Recruiting

Tampa, Florida 33614, United States; Recruiting

Jacksonville, Florida 32259, United States; Recruiting

Tampa, Florida 33615, United States; Recruiting

Pinellas Park, Florida 33781, United States; Recruiting

Ormond Beach, Florida 32174, United States; Recruiting

Atlanta, Georgia 30308, United States; Recruiting

Atlanta, Georgia 30329, United States; Recruiting

Atlanta, Georgia 30342, United States; Recruiting

Chicago, Illinois 60612, United States; Recruiting

Peoria, Illinois 61614, United States; Recruiting

Morton, Illinois 61550, United States; Terminated

Gurnee, Illinois 60031, United States; Recruiting

Evansville, Indiana 47714, United States; Recruiting

Baton-Rouge, Louisiana 70809, United States; Recruiting

St Louis, Missouri 63141, United States; Recruiting

Florissant, Missouri 63031, United States; Recruiting

Raleigh, North Carolina 27612, United States; Terminated

Winston-Salem, North Carolina 27103, United States; Recruiting

Perrysburg, Ohio 43551, United States; Recruiting

Cincinnati, Ohio 45219, United States; Recruiting

Columbus, Ohio 43212, United States; Recruiting

Wallingford, Pennsylvania 19086, United States; Recruiting

Cranston, Rhode Island 02920, United States; Recruiting

Memphis, Tennessee 38119, United States; Recruiting

Cordova, Tennessee 38018, United States; Terminated

San Antonio, Texas 78205, United States; Recruiting

Dallas, Texas 75235, United States; Recruiting

Dallas, Texas 75231, United States; Recruiting

Roanoke, Virginia 24018, United States; Recruiting

Starting date: October 2007
Ending date: September 2008
Last updated: July 8, 2008