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A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)

NCT00527904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2010-08-31

Study results available
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Summary

This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).

Conditions

  • Gastric Ulcer

Interventions

DRUG

PN400 (VIMOVO)

Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.

DRUG

PN 400 (VIMOVO)

500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Principal Investigators

  • Everardus Orlemans, PhD · POZEN

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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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 NCT00527904 on ClinicalTrials.gov