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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063920
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : January 24, 2011
PRA Health Sciences
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: LT-NS001 Drug: Naprosyn® Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Gastric Ulcer by Endoscopy [ Time Frame: Baseline, Day 29, Day 57 and Day 85 ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Screening, Baseline, Days 15, 29, 57 and 85 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063920

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Sponsors and Collaborators
Logical Therapeutics
PRA Health Sciences
Principal Investigator: Jay L Goldstein, MD University of Illinois at Chicago, Department of Medicine

Responsible Party: K. Lea Sewell, M.D./Vice President Clinical Development, Logical Therapeutics, Inc. Identifier: NCT01063920     History of Changes
Other Study ID Numbers: LT-NS001-003
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by Logical Therapeutics:
Gastric Ulcers

Additional relevant MeSH terms:
Stomach Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action