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

January 20, 2011 updated by: Logical Therapeutics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

534

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Greystone Medical Research, LLC
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research
      • Surprise, Arizona, United States, 85340
        • Dedicated Clinical Research Inc.
      • Tucson, Arizona, United States, 85710
        • Radiant Research Inc.
      • Tucson, Arizona, United States, 85712
        • Adobe Gastroenterology Research, LLC
      • Tucson, Arizona, United States, 85741
        • Genova Clinical Research Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Burbank, California, United States, 91505
        • Theresa Sligh, MD
      • Lomeita, California, United States, 90274
        • Torrance Clinical Research
      • Los Angeles, California, United States, 90045
        • West Gastroenterology Associates
      • Mission HIlls, California, United States, 91345
        • Facey Medical Center
      • Palm Springs, California, United States, 92262
        • Desert Medical Group
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 35801
        • Medical Affiliated Research Center Inc.
      • San Diego, California, United States, 92114
        • Cynthia Schaeffer, MD
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Lynn Institute Of The Rockies
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Center for Clinical Research
    • Florida
      • Hialeah, Florida, United States, 33013
        • Eastern Clinical Research Unit
      • Inverness, Florida, United States, 33452
        • Nature Coast Clinical Research
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research Inc.
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research LLC
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33317
        • Gold Coast Research LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Thomas Schnitzer, MD
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Welborn Clinic
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center LLC
    • Kansas
      • Mission, Kansas, United States, 66202
        • Venture Resource Group Inc.
      • Overland Park, Kansas, United States, 66215
        • Pinnacle Medical Research
    • Louisiana
      • Bastrop, Louisiana, United States, 71201
        • Delta Research Partners LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterolgy Group Pc
      • Frederick, Maryland, United States, 21702
        • Arthritis and Osteoporosis Cener of Maryland
      • Hollywood, Maryland, United States, 20636
        • MidAtlantic Medical Research Centers/Bean Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Dynamic Clinical Research
      • St. Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Montana
      • Billings, Montana, United States, 59102
        • Montana Health Research Institute Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
      • Las Vegas, Nevada, United States, 89144
        • Affiliated Clinical Research Inc.
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Clifton-Wallington Medical Group
    • New York
      • New York, New York, United States, 10022
        • Research Across America
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28075
        • Carolina Digestive Health Associates PA
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research-Akron
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73116
        • Clinical Research Associates LLC
    • Oregon
      • Portland, Oregon, United States, 97739
        • Keith Klatt, MD
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Texas
      • Corsicana, Texas, United States, 75110
        • Corsicana Medical Research PLLC
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Houston, Texas, United States, 77079
        • Houston Endoscopy and Research Center
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77090
        • Houston Medical Research Associates
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
      • Waco, Texas, United States, 76708
        • Arthritis and Osteoporosis Clinic Research Center of Central Texas
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians Research Options LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LT-NS001
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Drug: LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
Active Comparator: Naprosyn®
Naprosyn® 500 mg b.i.d for 12 weeks
Drug: Naprosyn®
500 mg b.i.d. p.o. for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastric Ulcer by Endoscopy
Time Frame: Baseline, Day 29, Day 57 and Day 85
Baseline, Day 29, Day 57 and Day 85

Secondary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time Frame: Screening, Baseline, Days 15, 29, 57 and 85
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
Time Frame: Two separate days after Day 14, at least two weeks apart
Two separate days after Day 14, at least two weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Logical Therapeutics

Collaborators

PRA Health Sciences

Investigators

  • Principal Investigator: Jay L Goldstein, MD, University of Illinois at Chicago, Department of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-NS001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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