Back to resultsEvaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Esomeprazole 40mg
Pantoprazole 40mg
Lansoprazole 30mg
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, acid reflux, heartburn, PPI, Hispanic
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SIte
- Research Site
- Research Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00410592
Brief Title
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, acid reflux, heartburn, PPI, Hispanic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg
Intervention Type
Drug
Intervention Name(s)
Pantoprazole 40mg
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 30mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Compare nocturnal intragastric pH in Hispanic patients with GERD
Title
Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
Title
Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Illueca, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kathryn Collison
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research SIte
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Juan
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20456300
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
We'll reach out to this number within 24 hrs