A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients

Study Overview
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Brief Summary
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To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients

Official Title
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A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Calcium (13C)Carbonate
* Drug: Gastric acid inhibitors
* Other: Gastric pH monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator. Exclusion Criteria: Patients suspected to have hypothyroidism or hyperparathyroidism. Patients with hypercalcemia Patients with a history of gastric or duodenal surgery. Patients who have received the eradication therapy of Helicobacter pylori within six months prior to participation of the study. Patients with a prior or current history of Zollinger-Ellison syndrome. Patients with a history of surgery or treatment affecting gastroesophageal reflux. Patients who have been diagnosed with acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to participation of the study. Patients with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyspraxia. Patients scheduled for surgery requiring hospitalization or required surgery during the study period. Patients who have had either a prior or current history of chest pain due to heart disease or with chest pain suspected to have caused by heart disease within one year prior to participation of the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C13-CAC<br> | Drug: Calcium (13C)Carbonate<br>* C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.<br>Drug: Gastric acid inhibitors<br>* Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.<br>Other: Gastric pH monitoring<br>* Gastric pH monitoring was performed once under fasting condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13CO2 concentration in expired air. | Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms. | 5，10，15，20，25 and 30 minutes after C13-CAC administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH | Sensitivity and specificity of mean gastric pH for improvement of symptoms. | 1 hour prior to C13-CAC administration |