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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Southern Arizona VA Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT01128608
First received: May 21, 2010
Last updated: July 20, 2010
Last verified: April 2010

May 21, 2010
July 20, 2010
September 2009
October 2010   (final data collection date for primary outcome measure)
The Mechanism of GERD [ Time Frame: NA There is no exact timeframe. ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01128608 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of High PCO2 Solution on Esophageal Acid Sensation
The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.

To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Gastroesophageal Reflux Disease
  • 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.
  • 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: Control Group - Healthy Subjects
    Healthy volunteers with normal EGD.
    Intervention: Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion
  • Active Comparator: NERD Group
    Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.
    Intervention: Procedure: 24-Hr Esohpageal pH Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact: Marcia Willis, CCRC 520-792-1450 ext 2032 marcia.willis@va.gov
United States
 
NCT01128608
The Effect of PCO2 Solution
No
Ronnie Fass, M.D., Southern Arizona VA Health Care System
Southern Arizona VA Health Care System
Not Provided
Principal Investigator: Ronnie Fass, MD Southern Arizona Veterans Health Care System
Southern Arizona VA Health Care System
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP