View Clinical Trial (Medical Research Study)
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).
| City: |
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Tucson |
| State: |
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Arizona |
| Zip Code: |
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85723 |
| Conditions: |
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Gastroesophageal Reflux Disease |
| Purpose: |
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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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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01089959 |
| Primary Contact: |
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Principal Investigator
Ronnie Fass, MD
SAVAHCS
RONNIE FASS, MD
Phone: 520-792-1450 ext. 5139
Email: ronniefass@va.gov
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| Backup Contact: |
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Email: marcia.willis@va.gov
MARCIA R WILLIS, CCRC
Phone: 520-792-1450 ext. 2032
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| Location Contact: |
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Tucson, Arizona 85723
United States
Ronnie Fass, MD
Phone: 520-792-1450
Email: ronniefass@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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