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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00410592

Collaborator

(none)

Enrollment

Locations

Duration (Months)

11.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole 40mg Drug: Pantoprazole 40mg Drug: Lansoprazole 30mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome 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 Outcome 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Anaheim	California	United States
2	Research Site	Orange	California	United States
3	Research Site	San Diego	California	United States
4	Research Site	Miami	Florida	United States
5	Research Site	Chicago	Illinois	United States
6	Research SIte	Chapel Hill	North Carolina	United States
7	Research Site	Houston	Texas	United States
8	Research Site	San Juan		Puerto Rico