Official Title: “A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole 40mg
• Drug: Pantoprazole 40mg
• Drug: Lansoprazole 30mg

Primary Measures

• To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.

Secondary Measures

• Compare nocturnal intragastric pH in Hispanic patients with GERD
• Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
• Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 69 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Marta Illueca, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00410592

Study ID Number: D9612L00106

ClinicalTrials.gov Identifier: NCT00410592

Health Authority: United States: Food and Drug Administration