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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546507
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : October 13, 2010
Information provided by:
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I
Study Start Date : October 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A
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)

Primary Outcome Measures :
  1. Change from baseline in the WOMAC Composite Pain Score [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546507

  Hide Study Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
Mobile, Alabama, United States, 36608
United States, Arizona
Mesa, Arizona, United States, 85206
Tucson, Arizona, United States, 85710
Tucson, Arizona, United States, 85741
United States, California
Fair Oaks, California, United States, 95628
Pico Rivera, California, United States, 90660
Santa Barbara, California, United States, 93108
Torrance, California, United States, 90505
United States, Florida
DeLand, Florida, United States, 32720
Jacksonville, Florida, United States, 32259
Kissimmee, Florida, United States, 34741
Ocala, Florida, United States, 34474
Ormond Beach, Florida, United States, 32174
Pembroke Pines, Florida, United States, 33024
Pinellas Park, Florida, United States, 33781
Stuart, Florida, United States, 34996
Tampa, Florida, United States, 33614
Tampa, Florida, United States, 33615
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30329
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago, Illinois, United States, 60612
Gurnee, Illinois, United States, 60031
Morton, Illinois, United States, 61550
Peoria, Illinois, United States, 61614
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Louisiana
Baton-Rouge, Louisiana, United States, 70809
United States, Missouri
Florissant, Missouri, United States, 63031
St Louis, Missouri, United States, 63141
United States, North Carolina
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45219
Columbus, Ohio, United States, 43212
Perrysburg, Ohio, United States, 43551
United States, Pennsylvania
Wallingford, Pennsylvania, United States, 19086
United States, Rhode Island
Cranston, Rhode Island, United States, 02920
United States, Tennessee
Cordova, Tennessee, United States, 38018
Memphis, Tennessee, United States, 38119
United States, Texas
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75235
San Antonio, Texas, United States, 78205
United States, Virginia
Roanoke, Virginia, United States, 24018
Sponsors and Collaborators
Mika Pharma GmbH
Study Director: Medical Affairs Mika Pharma GmbH

Responsible Party: Bernd G. Seigfried, MIKA Pharma GmbH Identifier: NCT00546507     History of Changes
Other Study ID Numbers: TD-06-13
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents