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NCT02225067 Clinical Trial

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

Healthy Clinical Trial

Official title:
Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02225067
Other study ID # CAC-14-001
Secondary ID
Status Completed
Phase Phase 2
First received August 21, 2014
Last updated May 1, 2015
Start date August 2014
Est. completion date December 2014

Study information
Verified date May 2015
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Calcium (13C)Carbonate
Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate

Locations
Country Name City State
Japan OPHAC Hospital Osaka

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd. EPS Corporation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Other Gastric pH holding time ratio pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring from completion of pre-study examination to before C13-CAC adminitration No
Primary 13CO2 concentration in expired air 13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC8, tmax, ?z, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air 5,10,15,20,25,30,40,50,60,80,100 and 120minutes after C13-CAC administration No
Primary 24-hour gastric pH Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration from completion of pre-study examination to before C13-CAC adminitration No
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