Back to resultsA Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Calcium (13C)Carbonate
Gastric acid inhibitors
Gastric pH monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease
Eligibility Criteria
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.
Sites / Locations
- Akita University Hospital
- National Hospital Organization Hakodate Hospital
- Shimane University Hospital
- Kawasaki Medical School General Medical Center
- Kawasaki Medical School Hospital
- National Hospital Organization Matsumoto Medical Center
- Hyogo College Of Medicine College Hospital
- Osaka Saiseikai Nakatsu Hospital
- Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
- Hiratsuka stomach and intestines Hospital
- Nippon Medical School Hospital
- National Hospital Organization Yokohama Medical Center
- Yokohama City University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C13-CAC
Arm Description
Outcomes
Primary Outcome Measures
13CO2 concentration in expired air.
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
Secondary Outcome Measures
Gastric pH
Sensitivity and specificity of mean gastric pH for improvement of symptoms.
Full Information
NCT ID
NCT03284177
First Posted
September 11, 2017
Last Updated
March 28, 2019
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03284177
Brief Title
A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C13-CAC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Calcium (13C)Carbonate
Intervention Description
C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
Intervention Type
Drug
Intervention Name(s)
Gastric acid inhibitors
Intervention Description
Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.
Intervention Type
Other
Intervention Name(s)
Gastric pH monitoring
Intervention Description
Gastric pH monitoring was performed once under fasting condition.
Primary Outcome Measure Information:
Title
13CO2 concentration in expired air.
Description
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
Time Frame
5，10，15，20，25 and 30 minutes after C13-CAC administration.
Secondary Outcome Measure Information:
Title
Gastric pH
Description
Sensitivity and specificity of mean gastric pH for improvement of symptoms.
Time Frame
1 hour prior to C13-CAC administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Facility Name
National Hospital Organization Hakodate Hospital
City
Hakodate
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
Country
Japan
Facility Name
Kawasaki Medical School General Medical Center
City
Kurashiki
Country
Japan
Facility Name
Kawasaki Medical School Hospital
City
Kurashiki
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
Country
Japan
Facility Name
Hyogo College Of Medicine College Hospital
City
Nishinomiya
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
City
Tokyo
Country
Japan
Facility Name
Hiratsuka stomach and intestines Hospital
City
Tokyo
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
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