Skip to main content
OpenTrials
Completed

NCT Number: NCT03284177

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Akita University Hospital, Akita, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.

Exclusion criteria

  • Patients suspected to have hypothyroidism or hyperparathyroidism.
  • Patients with hypercalcemia
  • Patients with a history of gastric or duodenal surgery.
  • Patients who have received the eradication therapy of Helicobacter pylori within six months prior to participation of the study.
  • Patients with a prior or current history of Zollinger-Ellison syndrome.
  • Patients with a history of surgery or treatment affecting gastroesophageal reflux.
  • Patients who have been diagnosed with acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to participation of the study.
  • Patients with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyspraxia.
  • Patients scheduled for surgery requiring hospitalization or required surgery during the study period.
  • Patients who have had either a prior or current history of chest pain due to heart disease or with chest pain suspected to have caused by heart disease within one year prior to participation of the study.

Treatment and study plan

Calcium (13C)Carbonate

Drug

C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.

Gastric acid inhibitors

Drug

Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.

Gastric pH monitoring

Other

Gastric pH monitoring was performed once under fasting condition.

Primary outcomes

  1. 13CO2 concentration in expired air.

    Time frame: 5,10,15,20,25 and 30 minutes after C13-CAC administration.

    Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.

Secondary outcomes

  1. Gastric pH

    Time frame: 1 hour prior to C13-CAC administration

    Sensitivity and specificity of mean gastric pH for improvement of symptoms.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.