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NCT00410592 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00410592
Other study ID # D9612L00106
Secondary ID
Status Completed
Phase Phase 4
First received December 12, 2006
Last updated March 10, 2009
Start date October 2006
Est. completion date May 2007

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole 40mg

• Pantoprazole 40mg

• Lansoprazole 30mg

Locations
Country Name City State
Puerto Rico Research Site San Juan
United States Research Site Anaheim California
United States Research SIte Chapel Hill North Carolina
United States Research Site Chicago Illinois
United States Research Site Houston Texas
United States Research Site Miami Florida
United States Research Site Orange California
United States Research Site San Diego California

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Compare nocturnal intragastric pH in Hispanic patients with GERD
Secondary Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
Secondary Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
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