Gastroesophageal Reflux Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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