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

May 1, 2015 updated by: Otsuka Pharmaceutical Co., Ltd.

Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 532-0003
        • OPHAC Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C13-CAC
Drug: Calcium (13C)Carbonate
Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
13CO2 concentration in expired air
Time Frame: 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
5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration
24-hour gastric pH
Time Frame: 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
from completion of pre-study examination to before C13-CAC adminitration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric pH holding time ratio
Time Frame: from completion of pre-study examination to before C13-CAC adminitration
pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring
from completion of pre-study examination to before C13-CAC adminitration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Collaborators

EPS Corporation

Investigators

  • Study Director: Kimiyoshi Sudoh, Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAC-14-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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