CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 276 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Esomeprazole 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00660660
NCT00660660Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

AstraZeneca·interventional·Posted Apr 17, 2008·Updated Mar 2, 2015

In Brief

A Phase 4 clinical trial evaluating Esomeprazole and Placebo for Gastroesophageal Reflux Disease. Completed, enrolled 276 participants across 45 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartApr 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.2 years ago

Interventions

Esomeprazoledrug

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

Placebodrug

once daily