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Completed

NCT Number: NCT01063920

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

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).

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Key information

Conditions

Osteoarthritis Arthritis Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Peptic Ulcer Rheumatic Diseases Stomach Diseases Stomach Ulcer

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Greystone Medical Research, LLC, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LT-NS001

Drug

1200 mg b.i.d. p.o. for 12 weeks

Naprosyn®

Drug

500 mg b.i.d. p.o. for 12 weeks

Primary outcomes

  1. Gastric Ulcer by Endoscopy

    Time frame: Baseline, Day 29, Day 57 and Day 85

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Logical Therapeutics

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2010
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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