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

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

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

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Calcium (13C)Carbonate; Drug: Gastric acid inhibitors; Other: Gastric pH monitoring

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan
    • Akita University Hospital
  • Hakodate, Japan
    • National Hospital Organization Hakodate Hospital
  • Izumo, Japan
    • Shimane University Hospital
  • Kurashiki, Japan
    • Kawasaki Medical School Hospital
  • Kurashiki, Japan
    • Kawasaki Medical School General Medical Center
  • Matsumoto, Japan
    • National Hospital Organization Matsumoto Medical Center
  • Nishinomiya, Japan
    • Hyogo College of Medicine College Hospital
  • Osaka, Japan
    • Osaka Saiseikai Nakatsu Hospital
  • Tokyo, Japan
    • Nippon Medical School Hospital
  • Tokyo, Japan
    • Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
  • Tokyo, Japan
    • Hiratsuka stomach and intestines Hospital
  • Yokohama, Japan
    • Yokohama City University Hospital
  • Yokohama, Japan
    • National Hospital Organization Yokohama Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2017
• Primary Completion (ACTUAL): December 4, 2018
• Study Completion (ACTUAL): December 4, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 334-103-00001; JapicCTI-173713 (REGISTRY: Japic Clinical Trials Information)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No