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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00410592

Purpose

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	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole 40mg Drug: Pantoprazole 40mg Drug: Lansoprazole 30mg	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Pantoprazole Lansoprazole Pantoprazole Sodium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

Estimated Enrollment:	90
Study Start Date:	October 2006
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410592

Locations

United States, California
Research Site
Anaheim, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, North Carolina
Research SIte
Chapel Hill, North Carolina, United States
United States, Texas
Research Site
Houston, Texas, United States
Puerto Rico
Research Site
San Juan, Puerto Rico

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Marta Illueca, MD	AstraZeneca
Study Chair:	Kathryn Collison	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00106
Study First Received:	December 12, 2006
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00410592 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

GERD
acid reflux
heartburn
PPI
Hispanic

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Pantoprazole
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux

Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on February 09, 2010