At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 420 enrolled
Drug / intervention
PN400 (VIMOVO) +1 moredrug
Likely dose
PN400 (VIMOVO) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers
In Brief
A Phase 3 clinical trial evaluating PN400 (VIMOVO) and Naproxen for Gastric Ulcer. Completed, enrolled 420 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Ulcer
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
Primary CompletionSep 2008
Study CompletionOct 2008
First PostedMay 2010
TodayJul 2026
First PostedMay 24, 2010
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.1 years ago
Interventions
PN400 (VIMOVO)drug
PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
Naproxendrug
Naproxen 500 mg dosed twice daily (bid) orally