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

Otsuka

Status and phase

Completed

Phase 2

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Calcium (13C)Carbonate

Other: Gastric pH monitoring

Drug: Gastric acid inhibitors

Study type

Interventional

Funder types

Industry

Identifiers

NCT03284177

JapicCTI-173713 (Registry Identifier)

334-103-00001

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

All

Ages

20 to 89 years old

Volunteers

No Healthy Volunteers

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.