Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Pantoprazole 40mg; Drug: Lansoprazole 30mg; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410592

D9612L00106

Details and patient eligibility

About

This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Males and females ages 18-69 who are of Hispanic origin
• Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months

Exclusion criteria

• Female patients who are pregnant or breastfeeding
• Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
• Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)