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

Sponsor:	Mika Pharma GmbH
Information provided by:	Mika Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00546507

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: TDS-943 (topical diclofenac sodium 4% spray) Drug: celecoxib Other: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Celecoxib

U.S. FDA Resources

Further study details as provided by Mika Pharma GmbH:

Primary Outcome Measures:

Change from baseline in the WOMAC Composite Pain Score [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment:	650
Study Start Date:	October 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A placebo	Other: placebo
Active Comparator: B celecoxib 200 mg qd p.o.	Drug: celecoxib
Experimental: C TDS-943 40 mg bid topically	Drug: TDS-943 (topical diclofenac sodium 4% spray)

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546507

Show 43 Study Locations

Sponsors and Collaborators

Mika Pharma GmbH

Investigators

Study Director:

Medical Affairs

Mika Pharma GmbH

More Information

No publications provided

Responsible Party:	Bernd G. Seigfried, MIKA Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00546507 History of Changes
Other Study ID Numbers:	TD-06-13
Study First Received:	October 17, 2007
Last Updated:	October 11, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012