Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
1 other identifier
interventional
650
1 country
49
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
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
November 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)
1
PLACEBO COMPARATORplacebo
2
ACTIVE COMPARATORcelecoxib 200 mg qd p.o.
3
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 (49)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Birmingham, Alabama, 35244, United States
Unknown Facility
Chandler, Arizona, 85225, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Foothill Ranch, California, 92610, United States
Unknown Facility
Irvine, California, 92618, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Danbury, Connecticut, 06810, United States
Unknown Facility
Milford, Connecticut, 06460, United States
Unknown Facility
Stanford, Connecticut, 06905, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
Unknown Facility
Delray Beach, Florida, 33484, United States
Unknown Facility
New Smyrna Beach, Florida, 32168, United States
Unknown Facility
Ococee, Florida, 34761, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
St. Petersburg, Florida, 33702, United States
Unknown Facility
Blue Ridge, Georgia, 30513, United States
Unknown Facility
Marietta, Georgia, 30066, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Overland Park, Kansas, 66202, United States
Unknown Facility
Towson, Maryland, 21286, United States
Unknown Facility
Brockton, Massachusetts, 02301, United States
Unknown Facility
Kalamazoo, Michigan, 49009, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
Omaha, Nebraska, 68144, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
Medford, New Jersey, 08055, United States
Unknown Facility
Brooklyn, New York, 11214, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Marion, Ohio, 43302, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Bensalem, Pennsylvania, 19020, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Charleston, South Carolina, 29406, United States
Unknown Facility
Austin, Texas, 78704, United States
Unknown Facility
Nederland, Texas, 77627, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Virginia Beach, Virginia, 23455, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, 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
November 1, 2008
Last Updated
October 13, 2010
Record last verified: 2010-10