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
Recruitment status was Recruiting
Sponsor:
Southern Arizona VA Health Care System
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
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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 Blind (Subject) 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. ] [ 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.
| 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | May 21, 2010 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 22, 2013