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Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

NCT00660660 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2015-03-02

Study results available
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Summary

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Esomeprazole

Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate

DRUG

Placebo

once daily

Sponsors & Collaborators

Principal Investigators

  • Tore Lind, MD · AstraZeneca

  • Kurt Brown, MD · AstraZeneca

  • David Johnson, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00660660 on ClinicalTrials.gov