NCT00818870

Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

A Randomized, Open-Label, Cross-Over, Dose-Ranging Study to Assess the Effect of Vecam 40/300 and Vecam 20/300 Administered at Bedtime Compared to Omeprazole 20 mg Administered Before Breakfast on Gastric pH

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vecta Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.

Detailed description

Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments. All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised. This study is part of the Vecam clinical development plan.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Omeprazole	20 mg capsule, orally, once daily (before breakfast) for 5 days.
DRUG	Vecam	1 capsule, orally, once daily at bedtime for 5 days.
DRUG	Vecam	1 capsule, orally, once daily at bedtime for 5 days.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-01-08
• Last updated: 2010-01-27

Locations

1 site across 1 country: United States