Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring

Otsuka Pharmaceutical Co., Ltd.40 enrolled

Overview

The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastric Acid-related Diseases Healthy

Interventions

Calcium (13C)CarbonateDRUG

Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment * Healthy subjects who are determined no history of Helicobacter pylori infections Exclusion Criteria: * Patients with hypercalcemia * Patients with hypothyroidism * Patients with hyperparathyroidism * History of upper gastrointestinal surgery or resection * Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Locations (1)

OPHAC Hospital

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

13CO2 concentration in expired air

13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air

Time frame: 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration

24-hour gastric pH

Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration

Time frame: from completion of pre-study examination to before C13-CAC adminitration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.