Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
NCT ID: NCT01063920
Last Updated: 2011-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
534 participants
INTERVENTIONAL
2010-02-28
2010-11-30
Brief Summary
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Detailed Description
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The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LT-NS001
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
Naprosyn®
Naprosyn® 500 mg b.i.d for 12 weeks
Naprosyn®
500 mg b.i.d. p.o. for 12 weeks
Interventions
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LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
Naprosyn®
500 mg b.i.d. p.o. for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.
Exclusion Criteria
* History of GI bleeding, perforation or obstruction
* A documented symptomatic GI ulcer during past 5 years
* Presence of GI ulcer or more than 2 erosions on screening endoscopy
* Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID drug
45 Years
80 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
Logical Therapeutics
INDUSTRY
Responsible Party
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Logical Therapeutics, Inc.
Principal Investigators
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Jay L Goldstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago, Department of Medicine
Locations
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Greystone Medical Research, LLC
Birmingham, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Radiant Research
Chandler, Arizona, United States
Dedicated Clinical Research Inc.
Surprise, Arizona, United States
Radiant Research Inc.
Tucson, Arizona, United States
Adobe Gastroenterology Research, LLC
Tucson, Arizona, United States
Genova Clinical Research Inc.
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Orange County Clinical Trials
Anaheim, California, United States
Theresa Sligh, MD
Burbank, California, United States
Torrance Clinical Research
Lomeita, California, United States
West Gastroenterology Associates
Los Angeles, California, United States
Facey Medical Center
Mission Hills, California, United States
Desert Medical Group
Palm Springs, California, United States
Medical Affiliated Research Center Inc.
San Diego, California, United States
Cynthia Schaeffer, MD
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Eastern Clinical Research Unit
Hialeah, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Drug Study Institute
Jupiter, Florida, United States
University Clinical Research Inc.
Pembroke Pines, Florida, United States
Radiant Research
Pinellas Park, Florida, United States
Accord Clinical Research LLC
Port Orange, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Gold Coast Research LLC
Weston, Florida, United States
Thomas Schnitzer, MD
Chicago, Illinois, United States
Welborn Clinic
Evansville, Indiana, United States
MediSphere Medical Research Center LLC
Evansville, Indiana, United States
Venture Resource Group Inc.
Mission, Kansas, United States
Pinnacle Medical Research
Overland Park, Kansas, United States
Delta Research Partners LLC
Bastrop, Louisiana, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
Metropolitan Gastroenterolgy Group PC
Chevy Chase, Maryland, United States
Arthritis and Osteoporosis Cener of Maryland
Frederick, Maryland, United States
MidAtlantic Medical Research Centers/Bean Medical Center
Hollywood, Maryland, United States
Dynamic Clinical Research
Kansas City, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Montana Health Research Institute Inc.
Billings, Montana, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Affiliated Clinical Research Inc.
Las Vegas, Nevada, United States
Clifton-Wallington Medical Group
Clifton, New Jersey, United States
Research Across America
New York, New York, United States
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, United States
Carolina Digestive Health Associates PA
Charlotte, North Carolina, United States
Peters Medical Research LLC
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiant Research-Akron
Akron, Ohio, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Clinical Research Associates LLC
Oklahoma City, Oklahoma, United States
Keith Klatt, MD
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Corsicana Medical Research PLLC
Corsicana, Texas, United States
Galenos Research
Dallas, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Houston Medical Research Associates
Houston, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Arthritis and Osteoporosis Clinic Research Center of Central Texas
Waco, Texas, United States
Physicians Research Options LLC
Draper, Utah, United States
Countries
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Other Identifiers
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LT-NS001-003
Identifier Type: -
Identifier Source: org_study_id
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