Recruiting
Phase 2
Phase 3

Esomeprazole

Sponsor:

Southern Arizona VA Health Care System

Code:

NCT01089959

Conditions

Gastroesophageal Reflux Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Esomeprazole

esomeprazole

Study Details

Brief summary:

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.

Conditions

Gastroesophageal Reflux Disease

Study ID

NCT01089959

Start date

Mar, 2010

Status verified date

Aug, 2010

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Esomeprazole

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

Interventions

Esomeprazole

40 mg daily for 7 days

esomeprazole

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

Primary outcome measure

  • The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

RONNIE FASS, MD

520-792-1450ronniefass@va.gov

MARCIA R WILLIS, CCRC

520-792-1450marcia.willis@va.gov

Locations

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Ronnie Fass, MD

520-792-1450ronniefass@va.gov

Principal Investigator:

RONNIE FASS, MD

More Information

Sponsor

Southern Arizona VA Health Care System

Last update posted

Aug 19, 2010

Last verified

Aug, 2010

Keywords

  • Acid re-flux,GERD
  • sleep related arousals due to GERD
  • Treatment of acid reflux during sleep in patients with GERD.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern Arizona VA Health Care System on 2010-08-19.