Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®

Last updated: January 20, 2011
Sponsor: Logical Therapeutics
Overall Status: Completed

Phase

2/3

Condition

Osteoarthritis

Ulcers

Treatment

N/A

Clinical Study ID

NCT01063920
LT-NS001-003
  • Ages 45-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Osteoarthritis of knee

  • Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on mostdays in the 28 days before screening for study.

Exclusion

Exclusion Criteria:

  • 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 NSAIDdrug

Study Design

Total Participants: 534
Study Start date:
February 01, 2010
Estimated Completion Date:
November 30, 2010

Study 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.

Connect with a study center

  • Greystone Medical Research, LLC

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • Clinical Research Associates

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Radiant Research

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Dedicated Clinical Research Inc.

    Surprise, Arizona 85340
    United States

    Site Not Available

  • Adobe Gastroenterology Research, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Genova Clinical Research Inc.

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Radiant Research Inc.

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Orange County Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Theresa Sligh, MD

    Burbank, California 91505
    United States

    Site Not Available

  • Torrance Clinical Research

    Lomeita, California 90274
    United States

    Site Not Available

  • West Gastroenterology Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Facey Medical Center

    Mission HIlls, California 91345
    United States

    Site Not Available

  • Desert Medical Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Cynthia Schaeffer, MD

    San Diego, California 92114
    United States

    Site Not Available

  • Medical Affiliated Research Center Inc.

    San Diego, California 35801
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Site Not Available

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Rocky Mountain Center for Clinical Research

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Eastern Clinical Research Unit

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 33452
    United States

    Site Not Available

  • Drug Study Institute

    Jupiter, Florida 33458
    United States

    Site Not Available

  • University Clinical Research Inc.

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Radiant Research

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Accord Clinical Research LLC

    Port Orange, Florida 32129
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Gold Coast Research LLC

    Weston, Florida 33317
    United States

    Site Not Available

  • Thomas Schnitzer, MD

    Chicago, Illinois 60611
    United States

    Site Not Available

  • MediSphere Medical Research Center LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Welborn Clinic

    Evansville, Indiana 47710
    United States

    Site Not Available

  • Venture Resource Group Inc.

    Mission, Kansas 66202
    United States

    Site Not Available

  • Pinnacle Medical Research

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Delta Research Partners LLC

    Bastrop, Louisiana 71201
    United States

    Site Not Available

  • SNBL Clinical Pharmacology Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Metropolitan Gastroenterolgy Group PC

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Arthritis and Osteoporosis Cener of Maryland

    Frederick, Maryland 21702
    United States

    Site Not Available

  • MidAtlantic Medical Research Centers/Bean Medical Center

    Hollywood, Maryland 20636
    United States

    Site Not Available

  • Dynamic Clinical Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Sundance Clinical Research

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Montana Health Research Institute Inc.

    Billings, Montana 59102
    United States

    Site Not Available

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Affiliated Clinical Research Inc.

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Clifton-Wallington Medical Group

    Clifton, New Jersey 07013
    United States

    Site Not Available

  • Research Across America

    New York, New York 10022
    United States

    Site Not Available

  • Allergy Asthma Immunology of Rochester Research Center

    Rochester, New York 14618
    United States

    Site Not Available

  • Carolina Digestive Health Associates PA

    Charlotte, North Carolina 28075
    United States

    Site Not Available

  • Peters Medical Research LLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Radiant Research-Akron

    Akron, Ohio 44311
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Clinical Research Associates LLC

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Keith Klatt, MD

    Portland, Oregon 97739
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Corsicana Medical Research PLLC

    Corsicana, Texas 75110
    United States

    Site Not Available

  • Galenos Research

    Dallas, Texas 75251
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Houston Endoscopy and Research Center

    Houston, Texas 77079
    United States

    Site Not Available

  • Houston Medical Research Associates

    Houston, Texas 77090
    United States

    Site Not Available

  • Quality Research Inc.

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Arthritis and Osteoporosis Clinic Research Center of Central Texas

    Waco, Texas 76708
    United States

    Site Not Available

  • Physicians Research Options LLC

    Draper, Utah 84020
    United States

    Site Not Available

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