Gastroesophageal Reflux DiseasePC02NCT01128608
The Effect of High PCO2 Solution on Esophageal Acid Sensation
A study testing 24-Hr Esohpageal pH Monitoring and PCO2 Acid Perfusion and 0.1N HCI Perfusion in people with Gastroesophageal Reflux Disease, run by Southern Arizona VA Health Care System at 2 sites in United States.
Trial summary
To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- 24-Hr Esohpageal pH Monitoring and PCO2 Acid Perfusion and 0.1N HCI Perfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Ronnie Fass, M.D., 520-792-1450 ext. 5139, ronnie.fass@va.gov
Marcia Willis, CCRC, 792.1450 ext. 2032, marcia.willis@va.gov
- Recruiting
Southern Arizona Veterans Health Care System
Tucson, Arizona, 85723
Ronnie Fass, MD, 520-792-1450 ext. 5139, ronnie.fass@va.gov
Marcia Willis, CCRC, 520-792-1450 ext. 2032, marcia.willis@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- 24-Hr Esohpageal pH Monitoring, PCO2 Acid Perfusion and 0.1N HCI Perfusion
- Keywords
- GERD, Heartburn, Acid Reflux
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-Hr Esohpageal pH MonitoringProcedure or surgery
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 PerfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Healthy Subjects | Active comparator | Healthy volunteers with normal EGD. Receives: Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion |
| NERD Group | Active comparator | Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH. Receives: Procedure: 24-Hr Esohpageal pH Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mechanism of GERD
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.
Measured: NA There is no exact timeframe.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Arizona VA Health Care System
- Sponsor type
- US federal agency
- Investigators
- Ronnie Fass, MD, Principal investigator, Southern Arizona Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128608
- Sponsor's protocol ID
- The Effect of PCO2 Solution
- Acronym
- PC02
- Status last verified
- Apr 2010
- First submitted
- 21 May 2010
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.
- ClinicalTrials.gov ID
- NCT01128608
- Acronym / sponsor ID
- PC02 / The Effect of PCO2 Solution
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Heartburn, Acid Reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Southern Arizona VA Health Care SystemUS federal agency
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Healthy Subjects | Active comparator | Procedure: PCO2 Acid Perfusion and 0.1N HCI PerfusionHealthy volunteers with normal EGD. |
| NERD Group | Active comparator | Procedure: 24-Hr Esohpageal pH MonitoringSubjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-Hr Esohpageal pH MonitoringThere 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 or surgery | NERD Group |
| PCO2 Acid Perfusion and 0.1N HCI PerfusionA 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. | Procedure or surgery | Control Group - Healthy Subjects |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Fass, MD principal investigator
Southern Arizona Veterans Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-Hr Esohpageal pH Monitoring and PCO2 Acid Perfusion and 0.1N HCI Perfusion in people with Gastroesophageal Reflux Disease, run by Southern Arizona VA Health Care System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia Willis, CCRC (520-792-1450 ext. 2032, marcia.willis@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mechanism of GERD (time frame: NA There is no exact timeframe.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2010.