The Effect of High PCO2 Solution on Esophageal Acid Sensation
NCT ID: NCT01128608
Last Updated: 2010-07-21
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2009-09-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Control Group - Healthy Subjects
Healthy volunteers with normal EGD.
PCO2 Acid Perfusion and 0.1N HCI Perfusion
A small tube will be inserted through the nostril and into the esophagus. A mild CO2 solution or a mild saline solution will be administered for aprox. 10 minutes during which you will be asked questions regarding any symptoms you may experience.
NERD Group
Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.
24-Hr Esohpageal pH Monitoring
There will be a 24-hr pH monitoring procedure and two 10-minute infusions each one week apart consisting of high PCO2 solution and 0.1 N HCI solution.
Interventions
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24-Hr Esohpageal pH Monitoring
There will be a 24-hr pH monitoring procedure and two 10-minute infusions each one week apart consisting of high PCO2 solution and 0.1 N HCI solution.
PCO2 Acid Perfusion and 0.1N HCI Perfusion
A small tube will be inserted through the nostril and into the esophagus. A mild CO2 solution or a mild saline solution will be administered for aprox. 10 minutes during which you will be asked questions regarding any symptoms you may experience.
Eligibility Criteria
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Inclusion Criteria
* Normal EGD, Normal 24-hr pH
* 18-80 Years of age
* Able to read, understand and complete study questionnaires and diary
* Able to understand study procedures and sign informed consent
* Albe to comply with all study requirements
10 NERD (Non-Erosive Reflux Disease)
* 18-80 Years of age
* Willing to stop PPI/H2 Blocker prior to EGD
* Have heartburn symptoms 2+ times per week for at least 3 months.
Exclusion Criteria
* Previous esophageal, gastric or duodenal surgery
* underlying co-morbidities
* Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder
* Upper airway symptoms
* Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics
* Patients who cannot or are unwilling to sign ICF
18 Years
80 Years
ALL
Yes
Sponsors
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Southern Arizona VA Health Care System
FED
Responsible Party
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Southern Arizona VA Health Care System
Principal Investigators
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Ronnie Fass, MD
Role: PRINCIPAL_INVESTIGATOR
Southern Arizona Veterans Health Care System
Locations
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Southern Arizona VA Health Care System
Tucson, Arizona, United States
Southern Arizona Veterans Health Care System
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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The Effect of PCO2 Solution
Identifier Type: -
Identifier Source: org_study_id
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