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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LT-NS001
Naprosyn®
Sponsored by
Logical Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring LT-NS001, Gastric Ulcers, NSAID, Osteoarthritis, Naproxen

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Greystone Medical Research, LLC
  • Clinical Research Associates
  • Radiant Research
  • Dedicated Clinical Research Inc.
  • Radiant Research Inc.
  • Adobe Gastroenterology Research, LLC
  • Genova Clinical Research Inc.
  • Lynn Institute of the Ozarks
  • Orange County Clinical Trials
  • Theresa Sligh, MD
  • Torrance Clinical Research
  • West Gastroenterology Associates
  • Facey Medical Center
  • Desert Medical Group
  • Medical Affiliated Research Center Inc.
  • Cynthia Schaeffer, MD
  • Medical Associates Research Group
  • Lynn Institute of the Rockies
  • Rocky Mountain Center for Clinical Research
  • Eastern Clinical Research Unit
  • Nature Coast Clinical Research
  • Drug Study Institute
  • University Clinical Research Inc.
  • Radiant Research
  • Accord Clinical Research LLC
  • Miami Research Associates
  • Palm Beach Research Center
  • Gold Coast Research LLC
  • Thomas Schnitzer, MD
  • Welborn Clinic
  • MediSphere Medical Research Center LLC
  • Venture Resource Group Inc.
  • Pinnacle Medical Research
  • Delta Research Partners LLC
  • SNBL Clinical Pharmacology Center
  • Metropolitan Gastroenterolgy Group PC
  • Arthritis and Osteoporosis Cener of Maryland
  • MidAtlantic Medical Research Centers/Bean Medical Center
  • Dynamic Clinical Research
  • Sundance Clinical Research
  • Montana Health Research Institute Inc.
  • Advanced Biomedical Research of America
  • Affiliated Clinical Research Inc.
  • Clifton-Wallington Medical Group
  • Research Across America
  • Allergy Asthma Immunology of Rochester Research Center
  • Carolina Digestive Health Associates PA
  • Peters Medical Research LLC
  • Wake Research Associates
  • Radiant Research-Akron
  • Consultants for Clinical Research
  • Health Research of Oklahoma
  • Lynn Health Science Institute
  • Sooner Clinical Research
  • Clinical Research Associates LLC
  • Keith Klatt, MD
  • Altoona Center for Clinical Research
  • Corsicana Medical Research PLLC
  • Galenos Research
  • Clinical Trial Network
  • Houston Endoscopy and Research Center
  • Houston Medical Research Associates
  • Quality Research Inc.
  • Arthritis and Osteoporosis Clinic Research Center of Central Texas
  • Physicians Research Options LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LT-NS001

Naprosyn®

Arm Description

LT-NS001 1200 mg b.i.d. p.o. for 12 weeks

Naprosyn® 500 mg b.i.d for 12 weeks

Outcomes

Primary Outcome Measures

Gastric Ulcer by Endoscopy

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2010
Last Updated
January 20, 2011
Sponsor
Logical Therapeutics
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01063920
Brief Title
Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Logical Therapeutics
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
LT-NS001, Gastric Ulcers, NSAID, Osteoarthritis, Naproxen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LT-NS001
Arm Type
Experimental
Arm Description
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Arm Title
Naprosyn®
Arm Type
Active Comparator
Arm Description
Naprosyn® 500 mg b.i.d for 12 weeks
Intervention Type
Drug
Intervention Name(s)
LT-NS001
Intervention Description
1200 mg b.i.d. p.o. for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Naprosyn®
Intervention Description
500 mg b.i.d. p.o. for 12 weeks
Primary Outcome Measure Information:
Title
Gastric Ulcer by Endoscopy
Time Frame
Baseline, Day 29, Day 57 and Day 85
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time Frame
Screening, Baseline, Days 15, 29, 57 and 85
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay L Goldstein, MD
Organizational Affiliation
University of Illinois at Chicago, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greystone Medical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Dedicated Clinical Research Inc.
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Radiant Research Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Adobe Gastroenterology Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Genova Clinical Research Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orange County Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Theresa Sligh, MD
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Torrance Clinical Research
City
Lomeita
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
West Gastroenterology Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Facey Medical Center
City
Mission HIlls
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Desert Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Medical Affiliated Research Center Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
35801
Country
United States
Facility Name
Cynthia Schaeffer, MD
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Eastern Clinical Research Unit
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
33452
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
University Clinical Research Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Accord Clinical Research LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Gold Coast Research LLC
City
Weston
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Thomas Schnitzer, MD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
MediSphere Medical Research Center LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Venture Resource Group Inc.
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Pinnacle Medical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Delta Research Partners LLC
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Metropolitan Gastroenterolgy Group PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Arthritis and Osteoporosis Cener of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
MidAtlantic Medical Research Centers/Bean Medical Center
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Dynamic Clinical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Sundance Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Health Research Institute Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Affiliated Clinical Research Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Clifton-Wallington Medical Group
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Allergy Asthma Immunology of Rochester Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Carolina Digestive Health Associates PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Peters Medical Research LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Radiant Research-Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research Associates LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Keith Klatt, MD
City
Portland
State/Province
Oregon
ZIP/Postal Code
97739
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Corsicana Medical Research PLLC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Galenos Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Quality Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Arthritis and Osteoporosis Clinic Research Center of Central Texas
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Physicians Research Options LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

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

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