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

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 II

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

Birmingham, Alabama 35244, United States; Terminated

Birmingham, Alabama 35209, United States; Terminated

Phoenix, Arizona 85032, United States; Terminated

Chandler, Arizona 85225, United States; Recruiting

Little Rock, Arkansas 72205, United States; Recruiting

Irvine, California 92618, United States; Recruiting

Foothill Ranch, California 92610, United States; Recruiting

Westlake Village, California 91361, United States; Recruiting

Anaheim, California 92804, United States; Recruiting

Anaheim, California 92801, United States; Recruiting

Denver, Colorado 80209, United States; Recruiting

Stanford, Connecticut 06905, United States; Recruiting

Danbury, Connecticut 06810, United States; Recruiting

Milford, Connecticut 06460, United States; Terminated

Ococee, Florida 34761, United States; Recruiting

Sarasota, Florida 34239, United States; Terminated

St. Petersburg, Florida 33702, United States; Recruiting

Delray Beach, Florida 33484, United States; Terminated

Boynton Beach, Florida 33472, United States; Recruiting

New Smyrna Beach, Florida 32168, United States; Recruiting

Marietta, Georgia 30066, United States; Recruiting

Savannah, Georgia 31406, United States; Recruiting

Blue Ridge, Georgia 30513, United States; Terminated

Boise, Idaho 83702, United States; Recruiting

Chicago, Illinois 60611, United States; Recruiting

Overland Park, Kansas 66202, United States; Recruiting

Towson, Maryland 21286, United States; Recruiting

Brockton, Massachusetts 02301, United States; Recruiting

Kalamazoo, Michigan 49009, United States; Terminated

Kansas City, Missouri 64114, United States; Recruiting

Omaha, Nebraska 68144, United States; Recruiting

Medford, New Jersey 08055, United States; Terminated

Berlin, New Jersey 08009, United States; Recruiting

Brooklyn, New York 11214, United States; Terminated

Asheville, North Carolina 28801, United States; Recruiting

Cleveland, Ohio 44121, United States; Recruiting

Cincinnati, Ohio 45246, United States; Recruiting

Marion, Ohio 43302, United States; Recruiting

Oklahoma City, Oklahoma 73103, United States; Recruiting

Oklahoma City, Oklahoma 73112, United States; Recruiting

Duncansville, Pennsylvania 16635, United States; Recruiting

Bensalem, Pennsylvania 19020, United States; Recruiting

Charleston, South Carolina 29406, United States; Recruiting

San Antonio, Texas 78209, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Nederland, Texas 77627, United States; Recruiting

Austin, Texas 78704, United States; Recruiting

Virginia Beach, Virginia 23455, United States; Recruiting

Milwaukee, Wisconsin 53209, United States; Recruiting

Starting date: October 2007
Ending date: October 2008
Last updated: August 6, 2008