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

Gastroesophageal Reflux Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastroesophageal Reflux Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Esomeprazole40 mg daily for 7 days

Drug:esomeprazole40 mg. daily, oral medication, once daily for 7 days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Esomeprazole

Study Status

Unknown status

Start Date: March 2010

Completed Date: March 2012

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ronnie Fass, MD

Lead Sponsor: Southern Arizona VA Health Care System

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01089959

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