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

Phase 3

Completed

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

• Registration Number: NCT00546832
• Lead Sponsor: Mika Pharma GmbH

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-19
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-11
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	TDS-943 (topical diclofenac sodium 4% spray)	TDS-943 40 mg bid topically
1	placebo	placebo
2	celecoxib	celecoxib 200 mg qd p.o.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the WOMAC Composite Pain Score	30 days

Secondary Outcome Measures

Name	Time	Method
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	30 days