Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring

Otsuka

Status and phase: Completed; Phase 2

Conditions: Healthy; Gastric Acid-related Diseases

Treatments: Drug: Calcium (13C)Carbonate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02225067

CAC-14-001

Details and patient eligibility

About

The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment
• Healthy subjects who are determined no history of Helicobacter pylori infections

Exclusion criteria

• Patients with hypercalcemia
• Patients with hypothyroidism
• Patients with hyperparathyroidism
• History of upper gastrointestinal surgery or resection
• Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

C13-CAC

Experimental group

Treatment:

Drug: Calcium (13C)Carbonate