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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Calcium (13C)Carbonate; Drug: Gastric acid inhibitors; Other: Gastric pH monitoring

• Registration Number: NCT03284177
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-15
• Study Start: 2017-10-31
• Primary Completion: 2018-12-04
• Study Completion: 2018-12-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C13-CAC	Calcium (13C)Carbonate	-
C13-CAC	Gastric acid inhibitors	-
C13-CAC	Gastric pH monitoring	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gastric pH	1 hour prior to C13-CAC administration	Sensitivity and specificity of mean gastric pH for improvement of symptoms.

Trial Locations

Locations (13)

Osaka Saiseikai Nakatsu Hospital; 🇯🇵 Osaka, Japan

Kawasaki Medical School Hospital; 🇯🇵 Kurashiki, Japan

Akita University Hospital; 🇯🇵 Akita, Japan

Shimane University Hospital; 🇯🇵 Izumo, Japan

National Hospital Organization Hakodate Hospital; 🇯🇵 Hakodate, Japan

Hiratsuka stomach and intestines Hospital; 🇯🇵 Tokyo, Japan

Nippon Medical School Hospital; 🇯🇵 Tokyo, Japan

National Hospital Organization Yokohama Medical Center; 🇯🇵 Yokohama, Japan

National Hospital Organization Matsumoto Medical Center; 🇯🇵 Matsumoto, Japan

Hyogo College Of Medicine College Hospital; 🇯🇵 Nishinomiya, Japan

Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency; 🇯🇵 Tokyo, Japan

Kawasaki Medical School General Medical Center; 🇯🇵 Kurashiki, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama, Japan