Calcium (13C)Carbonate
DrugC13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
NCT Number: NCT03284177
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
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Notify Me20 year–89 year
All sexes
Interventional
Phase 2
Akita University Hospital, Akita, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.
Gastric pH monitoring was performed once under fasting condition.
Time frame: 5,10,15,20,25 and 30 minutes after C13-CAC administration.
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
Time frame: 1 hour prior to C13-CAC administration
Sensitivity and specificity of mean gastric pH for improvement of symptoms.
Otsuka Pharmaceutical Co., Ltd.
Industry
A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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