Clinical trial NCT00410592: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
acid reflux
heartburn
PPI
Hispanic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: Compare nocturnal intragastric pH in Hispanic patients with GERD
measure: Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
measure: Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chapel Hill
country: United States
facility: Research SIte
state: North Carolina
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Marta Illueca, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Kathryn Collison
role: STUDY_CHAIR
References:
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.