Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring
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
1 other identifier
interventional
40
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 4, 2015
May 1, 2015
4 months
August 21, 2014
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
13CO2 concentration in expired air
13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, 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
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
Other Outcomes (1)
Gastric pH holding time ratio
from completion of pre-study examination to before C13-CAC adminitration
Study Arms (1)
C13-CAC
EXPERIMENTALInterventions
Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otsuka Pharmaceutical Co., Ltd.lead
- EPS Corporationcollaborator
Study Sites (1)
OPHAC Hospital
Osaka, Osaka, 532-0003, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kimiyoshi Sudoh
Otsuka Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2014
First Posted
August 25, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 4, 2015
Record last verified: 2015-05