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

Gastroesophageal Reflux Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284177
• Other study ID #: 334-103-00001
• Secondary ID: JapicCTI-173713
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2017
• Est. completion date: December 4, 2018

Study information

• Verified date: March 2019
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	National Hospital Organization Hakodate Hospital	Hakodate
Japan	Shimane University Hospital	Izumo
Japan	Kawasaki Medical School General Medical Center	Kurashiki
Japan	Kawasaki Medical School Hospital	Kurashiki
Japan	National Hospital Organization Matsumoto Medical Center	Matsumoto
Japan	Hyogo College Of Medicine College Hospital	Nishinomiya
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency	Tokyo
Japan	Hiratsuka stomach and intestines Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	National Hospital Organization Yokohama Medical Center	Yokohama
Japan	Yokohama City University Hospital	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13CO2 concentration in expired air.	Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.	5,10,15,20,25 and 30 minutes after C13-CAC administration.
Secondary	Gastric pH	Sensitivity and specificity of mean gastric pH for improvement of symptoms.	1 hour prior to C13-CAC administration