Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I
The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I
1 other identifier
interventional
650
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedOctober 13, 2010
October 1, 2010
1 year
October 17, 2007
October 11, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the WOMAC Composite Pain Score
30 days
Secondary Outcomes (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
30 days
Study Arms (3)
A
PLACEBO COMPARATORplacebo
B
ACTIVE COMPARATORcelecoxib 200 mg qd p.o.
C
EXPERIMENTALTDS-943 40 mg bid topically
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mika Pharma GmbHlead
Study Sites (43)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Mesa, Arizona, 85206, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
Fair Oaks, California, 95628, United States
Unknown Facility
Pico Rivera, California, 90660, United States
Unknown Facility
Santa Barbara, California, 93108, United States
Unknown Facility
Torrance, California, 90505, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Jacksonville, Florida, 32259, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Ocala, Florida, 34474, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Pinellas Park, Florida, 33781, United States
Unknown Facility
Stuart, Florida, 34996, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Tampa, Florida, 33615, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30329, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Gurnee, Illinois, 60031, United States
Unknown Facility
Morton, Illinois, 61550, United States
Unknown Facility
Peoria, Illinois, 61614, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Baton Rouge, Louisiana, 70809, United States
Unknown Facility
Florissant, Missouri, 63031, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Perrysburg, Ohio, 43551, United States
Unknown Facility
Wallingford, Pennsylvania, 19086, United States
Unknown Facility
Cranston, Rhode Island, 02920, United States
Unknown Facility
Cordova, Tennessee, 38018, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
San Antonio, Texas, 78205, United States
Unknown Facility
Roanoke, Virginia, 24018, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Affairs
Mika Pharma GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 19, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
October 13, 2010
Record last verified: 2010-10