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

Information source: Logical Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: LT-NS001 (Drug); Naprosyn® (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Logical Therapeutics

Official(s) and/or principal investigator(s):
Jay L Goldstein, MD, Principal Investigator, Affiliation: University of Illinois at Chicago, Department of Medicine

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Gastric Ulcer by Endoscopy

Secondary outcome:

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen

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.

Eligibility

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. 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 NSAID

drug

Locations and Contacts

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

Adobe Gastroenterology Research, LLC, Tucson, Arizona 85712, United States

Genova Clinical Research Inc., Tucson, Arizona 85741, United States

Radiant Research Inc., Tucson, Arizona 85710, 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

Cynthia Schaeffer, MD, San Diego, California 92114, United States

Medical Affiliated Research Center Inc., San Diego, California 35801, 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

MediSphere Medical Research Center LLC, Evansville, Indiana 47714, United States

Welborn Clinic, Evansville, Indiana 47710, 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

Clinical Research Associates LLC, Oklahoma City, Oklahoma 73116, 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

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

Additional Information

Starting date: February 2010
Last updated: January 20, 2011

Page last updated: August 23, 2015

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