Clinical trial NCT03284177: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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.

Primary outcomes:
measure: 13CO2 concentration in expired air.
timeFrame: 5，10，15，20，25 and 30 minutes after C13-CAC administration.
Secondary outcomes:
measure: Gastric pH
timeFrame: 1 hour prior to C13-CAC administration
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Akita University Hospital
city: Hakodate
country: Japan
facility: National Hospital Organization Hakodate Hospital
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Kurashiki
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Nishinomiya
country: Japan
facility: Hyogo College Of Medicine College Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
city: Tokyo
country: Japan
facility: Hiratsuka stomach and intestines Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
Study officials:
References: