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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00410592
First received: December 12, 2006
Last updated: March 10, 2009
Last verified: March 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00410592     History of Changes
Other Study ID Numbers: D9612L00106
Study First Received: December 12, 2006
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD
acid reflux
heartburn
PPI
Hispanic

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Pantoprazole
Omeprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014