Overview

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

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mika Pharma GmbH
Treatments:
Celecoxib
Diclofenac
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)