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...
Date First Received: October 17, 2007
Last Updated: July 8, 2008
Verified by: Wyeth, July 2008
Clinical Trial Phase: Phase 3 | Start Date: October 2007
Overall Status: Recruiting
Estimated Enrollment: 650
Brief Summary
Official Title: “The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Outcome Measures for this Clinical Trial
Primary:
- Change from baseline in the WOMAC Composite Pain Score 30 days No
Secondary:
- 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 30 days No
Criteria for Participation in this Clinical Trial
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)
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Wyeth
Birmingham Alabama 35244 United States
Birmingham Alabama 35209 United States
Phoenix Arizona 85032 United States
Chandler Arizona 85225 United States
Little Rock Arkansas 72205 United States
Irvine California 92618 United States
Foothill Ranch California 92610 United States
Westlake Village California 91361 United States
Anaheim California 92804 United States
Anaheim California 92801 United States
Denver Colorado 80209 United States
Stanford Connecticut 06905 United States
Danbury Connecticut 06810 United States
Milford Connecticut 06460 United States
Ococee Florida 34761 United States
Sarasota Florida 34239 United States
St. Petersburg Florida 33702 United States
Delray Beach Florida 33484 United States
Boynton Beach Florida 33472 United States
New Smyrna Beach Florida 32168 United States
Marietta Georgia 30066 United States
Savannah Georgia 31406 United States
Blue Ridge Georgia 30513 United States
Boise Idaho 83702 United States
Chicago Illinois 60611 United States
Overland Park Kansas 66202 United States
Towson Maryland 21286 United States
Brockton Massachusetts 02301 United States
Kalamazoo Michigan 49009 United States
Kansas City Missouri 64114 United States
Omaha Nebraska 68144 United States
Medford New Jersey 08055 United States
Berlin New Jersey 08009 United States
Brooklyn New York 11214 United States
Asheville North Carolina 28801 United States
Cleveland Ohio 44121 United States
Cincinnati Ohio 45246 United States
Marion Ohio 43302 United States
Oklahoma City Oklahoma 73103 United States
Oklahoma City Oklahoma 73112 United States
Duncansville Pennsylvania 16635 United States
Bensalem Pennsylvania 19020 United States
Charleston South Carolina 29406 United States
San Antonio Texas 78209 United States
San Antonio Texas 78229 United States
Nederland Texas 77627 United States
Austin Texas 78704 United States
Virginia Beach Virginia 23455 United States
Milwaukee Wisconsin 53209 United States
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Overall Contact: Trial Manager clintrialparticipation@wyeth.com
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546832
Study ID Number: TD-07-14
ClinicalTrials.gov Identifier: NCT00546832
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
