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The Effect of High PCO2 Solution on Esophageal Acid Sensation (PC02)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Southern Arizona VA Health Care System.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128608
First Posted: May 24, 2010
Last Update Posted: July 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southern Arizona VA Health Care System
  Purpose
To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

Condition Intervention
Gastroesophageal Reflux Disease Procedure: 24-Hr Esohpageal pH Monitoring Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.

Resource links provided by NLM:


Further study details as provided by Southern Arizona VA Health Care System:

Primary Outcome Measures:
  • The Mechanism of GERD [ Time Frame: NA There is no exact timeframe. ]
    Presently the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn sysmptoms is unclear. We aim to compare the effect of intraesophageal high PCO2 solution with saline solution on heartburn sensation.


Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group - Healthy Subjects
Healthy volunteers with normal EGD.
Procedure: 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.
Active Comparator: NERD Group
Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.
Procedure: 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.

Detailed Description:
Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

10 Healthy Controls

  • 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:

  • Esophageal erosions, Barretts, or peptic stricture on EGD
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128608


Contacts
Contact: Marcia Willis, CCRC 520-792-1450 ext 2032 marcia.willis@va.gov

Locations
United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Ronnie Fass, M.D.    520-792-1450 ext 5139    ronnie.fass@va.gov   
Contact: Marcia Willis, CCRC    792.1450 ext 2032    marcia.willis@va.gov   
Principal Investigator: Ronnie Fass, M.D.         
Southern Arizona Veterans Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Ronnie Fass, MD    520-792-1450 ext 5139    ronnie.fass@va.gov   
Contact: Marcia Willis, CCRC    520-792-1450 ext 2032    marcia.willis@va.gov   
Principal Investigator: Ronnie Fass, MD         
Sponsors and Collaborators
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Ronnie Fass, MD Southern Arizona Veterans Health Care System
  More Information

Responsible Party: Ronnie Fass, M.D., Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT01128608     History of Changes
Other Study ID Numbers: The Effect of PCO2 Solution
First Submitted: May 21, 2010
First Posted: May 24, 2010
Last Update Posted: July 21, 2010
Last Verified: April 2010

Keywords provided by Southern Arizona VA Health Care System:
GERD
Heartburn
Acid Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions


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