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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410592
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : March 11, 2009
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Primary Outcome Measures :
  1. 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 :
  1. Compare nocturnal intragastric pH in Hispanic patients with GERD
  2. Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
  3. Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410592

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00410592     History of Changes
Other Study ID Numbers: D9612L00106
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
acid reflux

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action