Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: Esomeprazole 40mg (Drug); Pantoprazole 40mg (Drug); Lansoprazole 30mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Marta Illueca, MD, Study Director, Affiliation: AstraZeneca
Kathryn Collison, Study Chair, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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: Compare nocturnal intragastric pH in Hispanic patients with GERDCompare 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
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, San Juan, Puerto Rico
Research Site, Anaheim, California, United States
Research Site, Orange, California, United States
Research Site, San Diego, California, United States
Research Site, Miami, Florida, United States
Research Site, Chicago, Illinois, United States
Research SIte, Chapel Hill, North Carolina, United States
Research Site, Houston, Texas, United States
Additional Information
Starting date: October 2006
Last updated: July 3, 2007
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