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

Phase 2

Completed

• Conditions: Gastric Acid-related Diseases; Healthy
• Interventions: Drug: Calcium (13C)Carbonate

• Registration Number: NCT02225067
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C13-CAC	Calcium (13C)Carbonate	-

Primary Outcome Measures

Name	Time	Method
24-hour gastric pH	from completion of pre-study examination to before C13-CAC adminitration	Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration
13CO2 concentration in expired air	5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration	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

Trial Locations

Locations (1)

OPHAC Hospital; 🇯🇵 Osaka, Japan