Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
- Registration Number
- NCT01063920
- Lead Sponsor
- Logical Therapeutics
- 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).
- Detailed Description
This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary objectives include assessment of pain in the affected knee by WOMAC questionnaire to demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information about gastrointestinal pain and tolerability will be collected.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LT-NS001 LT-NS001 LT-NS001 1200 mg b.i.d. p.o. for 12 weeks Naprosyn® Naprosyn® Naprosyn® 500 mg b.i.d for 12 weeks
- Primary Outcome Measures
Name Time Method Gastric Ulcer by Endoscopy Baseline, Day 29, Day 57 and Day 85
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (64)
SNBL Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States
Thomas Schnitzer, MD
🇺🇸Chicago, Illinois, United States
Cynthia Schaeffer, MD
🇺🇸San Diego, California, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Pinnacle Medical Research
🇺🇸Overland Park, Kansas, United States
Adobe Gastroenterology Research, LLC
🇺🇸Tucson, Arizona, United States
Genova Clinical Research Inc.
🇺🇸Tucson, Arizona, United States
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Delta Research Partners LLC
🇺🇸Bastrop, Louisiana, United States
Venture Resource Group Inc.
🇺🇸Mission, Kansas, United States
Orange County Clinical Trials
🇺🇸Anaheim, California, United States
Eastern Clinical Research Unit
🇺🇸Hialeah, Florida, United States
Dedicated Clinical Research Inc.
🇺🇸Surprise, Arizona, United States
MediSphere Medical Research Center LLC
🇺🇸Evansville, Indiana, United States
Arthritis and Osteoporosis Cener of Maryland
🇺🇸Frederick, Maryland, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Torrance Clinical Research
🇺🇸Lomeita, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Desert Medical Group
🇺🇸Palm Springs, California, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
University Clinical Research Inc.
🇺🇸Pembroke Pines, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Greystone Medical Research, LLC
🇺🇸Birmingham, Alabama, 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
Radiant Research Inc.
🇺🇸Tucson, Arizona, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Theresa Sligh, MD
🇺🇸Burbank, California, United States
West Gastroenterology Associates
🇺🇸Los Angeles, California, United States
Medical Affiliated Research Center Inc.
🇺🇸San Diego, California, United States
Gold Coast Research LLC
🇺🇸Weston, Florida, United States
Metropolitan Gastroenterolgy Group PC
🇺🇸Chevy Chase, Maryland, United States
MidAtlantic Medical Research Centers/Bean Medical Center
🇺🇸Hollywood, Maryland, United States
Sundance Clinical Research
🇺🇸St. Louis, Missouri, United States
Montana Health Research Institute Inc.
🇺🇸Billings, Montana, 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
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
Allergy Asthma Immunology of Rochester Research Center
🇺🇸Rochester, New York, United States
Radiant Research-Akron
🇺🇸Akron, Ohio, United States
Corsicana Medical Research PLLC
🇺🇸Corsicana, Texas, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Houston Medical Research Associates
🇺🇸Houston, Texas, United States
Arthritis and Osteoporosis Clinic Research Center of Central Texas
🇺🇸Waco, Texas, United States
Physicians Research Options LLC
🇺🇸Draper, Utah, United States
Dynamic Clinical Research
🇺🇸Kansas City, Missouri, United States
Keith Klatt, MD
🇺🇸Portland, Oregon, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Facey Medical Center
🇺🇸Mission HIlls, California, United States
Accord Clinical Research LLC
🇺🇸Port Orange, Florida, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Radiant Research
🇺🇸Pinellas Park, Florida, United States