Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.

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Detailed Description

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Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered.

Subjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esomeprazole

Effect of PPI esomeprazole on acid reflux \& related arousals during sleep in patients with GERD.

Group Type OTHER

Esomeprazole

Intervention Type DRUG

40 mg daily for 7 days

esomeprazole

Intervention Type DRUG

40 mg. daily, oral medication, once daily for 7 days.

Interventions

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Esomeprazole

40 mg daily for 7 days

Intervention Type DRUG

esomeprazole

40 mg. daily, oral medication, once daily for 7 days.

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium

Eligibility Criteria

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Inclusion Criteria

* Nocturnal symptoms at least twice a week.
* Ages 18-80
* Erosive esophagitis and/or abnormal pH test -
* Able to read, understand, and complete study questionnaires

Exclusion Criteria

* Subjects with Barrett's esophagus or peptic stricture on endoscopy
* Subjects with normal endoscopy and pH test
* Subjects with previous upper gastrointestinal surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No