Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

NCT ID: NCT00410592

Last Updated: 2009-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole 40mg

Intervention Type DRUG

Pantoprazole 40mg

Intervention Type DRUG

Lansoprazole 30mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Marta Illueca, MD

Role: STUDY_DIRECTOR

AstraZeneca

Kathryn Collison

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Anaheim, California, United States

Site Status

Research Site

Orange, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research SIte

Chapel Hill, North Carolina, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 20456300 (View on PubMed)

Other Identifiers

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D9612L00106

Identifier Type: -

Identifier Source: org_study_id

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