Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD (ISS)
|ClinicalTrials.gov Identifier: NCT01089959|
Recruitment Status : Unknown
Verified August 2010 by Southern Arizona VA Health Care System.
Recruitment status was: Recruiting
First Posted : March 19, 2010
Last Update Posted : August 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Esomeprazole Drug: esomeprazole||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With Gastroesophageal Reflux Disease (GERD).|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
Effect of PPI esomeprazole on acid reflux & related arousals during sleep in patients with GERD.
40 mg daily for 7 days
Other Name: Nexium
40 mg. daily, oral medication, once daily for 7 days.
Other Name: Nexium
- 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 ]
This is the first study to evaluate the impact of antireflux treatment, not only on heartburn during sleep, but also on reflux-related conscious awakenings.
This has not been done previously and will thus provide an opportunity to assess the impact of esomeprazole on nighttime symptoms and awakenings.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089959
|Contact: RONNIE FASS, MD||520-792-1450 ext firstname.lastname@example.org|
|Contact: MARCIA R WILLIS, CCRC||520-792-1450 ext email@example.com|
|United States, Arizona|
|Southern Arizona VA Health Care System||Recruiting|
|Tucson, Arizona, United States, 85723|
|Contact: Ronnie Fass, MD 520-792-1450 ext 5139 firstname.lastname@example.org|
|Principal Investigator: RONNIE FASS, MD|
|Principal Investigator:||Ronnie Fass, MD||SAVAHCS|