Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Phase 4
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT00410592
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
Name Time Method Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD Compare nocturnal intragastric pH in Hispanic patients with GERD Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
Trial Locations
- Locations (2)
Research Site
🇵🇷San Juan, Puerto Rico
Research SIte
🇺🇸Chapel Hill, North Carolina, United States