NCT01059383

Active Control, Double-blind, Double-dummy, Parallel-group, Randomized Study to Assess the Effect of VECAM 40/300, Administered at Bedtime, vs. Esomeprazole 20 mg, Administered 30-60 Min. Before Dinner, on Daytime and Nighttime GERD Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Vecta Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to assess the effect and safety of oral administration of VECAM 40/300 administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms. The rational for the study is based on the contention that VECAM exhibits potent inhibition of acid secretion and because of its mechanism of action, it can be administered at bedtime without food. Such timing of drug dosing will allow effective inhibition of nighttime acid secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of acid secretion and hence, its bedtime administration will not compromise its effect during the daytime. This improved control of acid secretion will predictably result in better control of nighttime as well as daytime heartburn (HB) symptoms.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	VECAM 40/300	1 capsule, orally, once daily at bedtime.
DRUG	Esomeprazole 20 mg	1 capsule, orally, once daily 30-60 min. before dinner

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-01-29
• Last updated: 2012-07-30

Locations

2 sites across 1 country: United States