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

NCT ID: NCT02225067

Last Updated: 2015-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Gastric Acid-related Diseases Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C13-CAC

Group Type EXPERIMENTAL

Calcium (13C)Carbonate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EPS Corporation

OTHER

Sponsor Role collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimiyoshi Sudoh

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

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OPHAC Hospital

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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CAC-14-001

Identifier Type: -

Identifier Source: org_study_id

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