Trial | NCT00546832  Report issue

Title

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    diclofenac celecoxib ...

  • Study Participants

    650
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.
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.
Study Started
Oct 31
2007
Primary Completion
Oct 31
2008
Study Completion
Nov 30
2008
Last Update
Oct 13
2010
Estimate

Drug TDS-943 (topical diclofenac sodium 4% spray)

Drug celecoxib

Other placebo

1 Placebo Comparator

placebo

2 Active Comparator

celecoxib 200 mg qd p.o.

3 Experimental

TDS-943 40 mg bid topically

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)
No Results Posted