Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
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
1 other identifier
interventional
90
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2006
Shorter than P25 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 12, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 11, 2009
March 1, 2009
December 12, 2006
March 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
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
Research Site
San Juan, Puerto Rico
Related Publications (1)
Morgan D, Pandolfino J, Katz PO, Goldstein JL, Barker PN, Illueca M. Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole. Aliment Pharmacol Ther. 2010 Jul;32(2):200-8. doi: 10.1111/j.1365-2036.2010.04335.x. Epub 2010 Apr 23.
PMID: 20456300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marta Illueca, MD
AstraZeneca
- STUDY CHAIR
Kathryn Collison
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 13, 2006
Study Start
October 1, 2006
Study Completion
May 1, 2007
Last Updated
March 11, 2009
Record last verified: 2009-03