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

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

NCT00546832

Run by

Mika Pharma GmbH

People needed

650

Starts

2007-10-01

Expected to finish

2008-11-01

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 — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Anaheim, California, United States
• Study site — Foothill Ranch, California, United States
• Study site — Irvine, California, United States
• Study site — Westlake Village, California, United States
• Study site — Denver, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Milford, Connecticut, United States
• Study site — Stanford, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — New Smyrna Beach, Florida, United States
• Study site — Ococee, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Blue Ridge, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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