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

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

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • placebo
• Active Comparator: B
  • celecoxib 200 mg qd p.o.
• Experimental: C
  • TDS-943 40 mg bid topically

Primary Measures

• Change from baseline in the WOMAC Composite Pain Score
  • Time Frame: 30 days
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: 30 days
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546507

Study ID Number: TD-06-13

ClinicalTrials.gov Identifier: NCT00546507

Health Authority: United States: Food and Drug Administration