Status:
COMPLETED
A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
20-89 years
Phase:
PHASE2
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
- GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.
Exclusion
- 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.
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03284177
Start Date
October 31 2017
End Date
December 4 2018
Last Update
April 1 2019
Active Locations (13)
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1
Akita University Hospital
Akita, Japan
2
National Hospital Organization Hakodate Hospital
Hakodate, Japan
3
Shimane University Hospital
Izumo, Japan
4
Kawasaki Medical School General Medical Center
Kurashiki, Japan