Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates
1 other identifier
interventional
534
1 country
65
Brief Summary
LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2010
Shorter than P25 for phase_2
65 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
First Submitted
Initial submission to the registry
January 29, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 24, 2011
January 1, 2011
9 months
January 29, 2010
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastric Ulcer by Endoscopy
Baseline, Day 29, Day 57 and Day 85
Secondary Outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Screening, Baseline, Days 15, 29, 57 and 85
Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen
Two separate days after Day 14, at least two weeks apart
Study Arms (2)
LT-NS001
EXPERIMENTALLT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Naprosyn®
ACTIVE COMPARATORNaprosyn® 500 mg b.i.d for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of knee
- Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.
You may not qualify if:
- Pregnant/Nursing women
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Logical Therapeuticslead
- PRA Health Sciencescollaborator
Study Sites (65)
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Radiant Research
Chandler, Arizona, 85225, United States
Dedicated Clinical Research Inc.
Surprise, Arizona, 85340, United States
Radiant Research Inc.
Tucson, Arizona, 85710, United States
Adobe Gastroenterology Research, LLC
Tucson, Arizona, 85712, United States
Genova Clinical Research Inc.
Tucson, Arizona, 85741, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Orange County Clinical Trials
Anaheim, California, 92801, United States
Theresa Sligh, MD
Burbank, California, 91505, United States
Torrance Clinical Research
Lomeita, California, 90274, United States
West Gastroenterology Associates
Los Angeles, California, 90045, United States
Facey Medical Center
Mission Hills, California, 91345, United States
Desert Medical Group
Palm Springs, California, 92262, United States
Medical Affiliated Research Center Inc.
San Diego, California, 35801, United States
Cynthia Schaeffer, MD
San Diego, California, 92114, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Eastern Clinical Research Unit
Hialeah, Florida, 33013, United States
Nature Coast Clinical Research
Inverness, Florida, 33452, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
University Clinical Research Inc.
Pembroke Pines, Florida, 33024, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Accord Clinical Research LLC
Port Orange, Florida, 32129, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Gold Coast Research LLC
Weston, Florida, 33317, United States
Thomas Schnitzer, MD
Chicago, Illinois, 60611, United States
Welborn Clinic
Evansville, Indiana, 47710, United States
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Venture Resource Group Inc.
Mission, Kansas, 66202, United States
Pinnacle Medical Research
Overland Park, Kansas, 66215, United States
Delta Research Partners LLC
Bastrop, Louisiana, 71201, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
Metropolitan Gastroenterolgy Group PC
Chevy Chase, Maryland, 20815, United States
Arthritis and Osteoporosis Cener of Maryland
Frederick, Maryland, 21702, United States
MidAtlantic Medical Research Centers/Bean Medical Center
Hollywood, Maryland, 20636, United States
Dynamic Clinical Research
Kansas City, Missouri, 64114, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Montana Health Research Institute Inc.
Billings, Montana, 59102, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Affiliated Clinical Research Inc.
Las Vegas, Nevada, 89144, United States
Clifton-Wallington Medical Group
Clifton, New Jersey, 07013, United States
Research Across America
New York, New York, 10022, United States
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, 14618, United States
Carolina Digestive Health Associates PA
Charlotte, North Carolina, 28075, United States
Peters Medical Research LLC
High Point, North Carolina, 27262, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Radiant Research-Akron
Akron, Ohio, 44311, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Clinical Research Associates LLC
Oklahoma City, Oklahoma, 73116, United States
Keith Klatt, MD
Portland, Oregon, 97739, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Corsicana Medical Research PLLC
Corsicana, Texas, 75110, United States
Galenos Research
Dallas, Texas, 75251, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Houston Endoscopy and Research Center
Houston, Texas, 77079, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Quality Research Inc.
San Antonio, Texas, 78209, United States
Arthritis and Osteoporosis Clinic Research Center of Central Texas
Waco, Texas, 76708, United States
Physicians Research Options LLC
Draper, Utah, 84020, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay L Goldstein, MD
University of Illinois at Chicago, Department of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 5, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 24, 2011
Record last verified: 2011-01