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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00546507

Run by

Mika Pharma GmbH

People needed

650

Starts

2007-10-01

Expected to finish

2008-10-01

Last updated by the study team

2010-10-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fair Oaks, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — DeLand, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Gurnee, Illinois, United States
• Study site — Morton, Illinois, United States

Full record on ClinicalTrials.gov

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