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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 May 2015 |
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Main ID: |
NCT02225067 |
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Date of registration:
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21/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring
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Scientific title:
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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 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02225067 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kimiyoshi Sudoh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Otsuka Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Acid-related Diseases
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Healthy
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Intervention(s)
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Drug: Calcium (13C)Carbonate
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Primary Outcome(s)
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13CO2 concentration in expired air
[Time Frame: 5,10,15,20,25,30,40,50,60,80,100 and 120minutes after C13-CAC administration]
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24-hour gastric pH
[Time Frame: from completion of pre-study examination to before C13-CAC adminitration]
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Secondary ID(s)
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CAC-14-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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