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

NCT03284177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-04-01

No results posted yet for this study

Summary

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

Conditions

  • Gastroesophageal Reflux Disease

Interventions

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-12-04
Completion
2018-12-04

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284177 on ClinicalTrials.gov