Completed PHASE3 INTERVENTIONAL 2-arm NCT00527787

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

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

Sponsor: POZEN

Conditions Gastric Ulcer

Interventions Naproxen PN400 (VIMOVO)

Updated 6 times since 2017 Last updated: Nov 29, 2010 Started: Sep 30, 2007 Primary completion: Oct 31, 2008 Completion: Oct 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Gastric Ulcer and is currently completed. POZEN leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

POZEN

Data source: POZEN

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Chapel Hill, United States