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Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

NCT01129011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2010-12-28

Study results available
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Summary

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Conditions

  • Gastric Ulcer

Interventions

DRUG

PN400 (VIMOVO)

PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.

DRUG

Naproxen

Naproxen 500 mg dosed twice daily (bid) orally

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Principal Investigators

  • Everardus Orlemans, PhD · POZEN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-09-30
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129011 on ClinicalTrials.gov