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

This study has been completed.
Sponsor:
Information provided by:
Mika Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00546507
First received: October 17, 2007
Last updated: October 11, 2010
Last verified: October 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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, 33615
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30329
Atlanta, Georgia, United States, 30308
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, 75235
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78205
United States, Virginia
Roanoke, Virginia, United States, 24018
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
Celecoxib
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014