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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-12-04

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

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C13-CAC

Group Type EXPERIMENTAL

Calcium (13C)Carbonate

Intervention Type DRUG

C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.

Gastric acid inhibitors

Intervention Type DRUG

Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.

Gastric pH monitoring

Intervention Type OTHER

Gastric pH monitoring was performed once under fasting condition.

Interventions

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Calcium (13C)Carbonate

C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.

Intervention Type DRUG

Gastric acid inhibitors

Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.

Intervention Type DRUG

Gastric pH monitoring

Gastric pH monitoring was performed once under fasting condition.

Intervention Type OTHER

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No