Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, acid reflux, heartburn, PPI, Hispanic
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Puerto Rico, United States
Outcome results
None listed