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

Phase 3 Completed 239 enrolled POZEN

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2007-03
Primary completion: 2009-03
Completion: 2009-03

Publications

Sostek MB, Fort JG, Estborn L, Vikman K. Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers. Curr Med Res Opin. 2011 Apr;27(4):847-54. doi: 10.1185/03007995.2011.555756. Epub 2011 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	20 mg	Oral
Subject	Naproxen	Small molecule	500 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications