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

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by:
Logical Therapeutics
ClinicalTrials.gov Identifier:
NCT01063920
First received: January 29, 2010
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: LT-NS001
Drug: Naprosyn®
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Logical Therapeutics:

Primary Outcome Measures:
  • Gastric Ulcer by Endoscopy [ Time Frame: Baseline, Day 29, Day 57 and Day 85 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Screening, Baseline, Days 15, 29, 57 and 85 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 534
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063920

  Show 65 Study Locations
Sponsors and Collaborators
Logical Therapeutics
PRA International
Investigators
Principal Investigator: Jay L Goldstein, MD University of Illinois at Chicago, Department of Medicine
  More Information

No publications provided

Responsible Party: K. Lea Sewell, M.D./Vice President Clinical Development, Logical Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01063920     History of Changes
Other Study ID Numbers: LT-NS001-003
Study First Received: January 29, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Logical Therapeutics:
LT-NS001
Gastric Ulcers
NSAID
Osteoarthritis
Naproxen

Additional relevant MeSH terms:
Osteoarthritis
Stomach Ulcer
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014