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

Phase 3

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: PN400 (VIMOVO); Drug: PN 400 (VIMOVO)

• Registration Number: NCT00527904
• Lead Sponsor: POZEN

Brief 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).

Detailed Description

PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-03-15
• Disposition First Submitted QC: 2010-03-15
• Disposition First Posted: 2010-03-17
• Results First Submitted: 2010-05-28
• Results First Submitted QC: 2010-07-23
• Status Verified: 2010-08
• Results First Posted: 2010-08-20
• Last Update Submitted: 2010-08-27
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PN 400 (VIMOVO)	PN400 (VIMOVO)	500 mg delayed release naproxen/20 mg immediate release esomeprazole
PN 400 (VIMOVO)	PN 400 (VIMOVO)	500 mg delayed release naproxen/20 mg immediate release esomeprazole

Primary Outcome Measures

Name	Time	Method
Number of Subjects Monitored for Long-term Safety of PN 400	12 months	Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.

Trial Locations

Locations (1)

POZEN; 🇺🇸 Chapel Hill, North Carolina, United States