Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-02 @ 1:06 AM
Study NCT ID:
NCT02225067
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastric pH holding time ratio', 'timeFrame': 'from completion of pre-study examination to before C13-CAC adminitration', 'description': 'pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring'}], 'primaryOutcomes': [{'measure': '13CO2 concentration in expired air', 'timeFrame': '5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration', 'description': '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'}, {'measure': '24-hour gastric pH', 'timeFrame': 'from completion of pre-study examination to before C13-CAC adminitration', 'description': 'Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients', 'Volunteers'], 'conditions': ['Gastric Acid-related Diseases', 'Healthy']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment\n* Healthy subjects who are determined no history of Helicobacter pylori infections\n\nExclusion Criteria:\n\n* Patients with hypercalcemia\n* Patients with hypothyroidism\n* Patients with hyperparathyroidism\n* History of upper gastrointestinal surgery or resection\n* Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring"}, 'identificationModule': {'nctId': 'NCT02225067', 'briefTitle': 'Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CAC-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C13-CAC', 'interventionNames': ['Drug: Calcium (13C)Carbonate']}], 'interventions': [{'name': 'Calcium (13C)Carbonate', 'type': 'DRUG', 'description': 'Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate', 'armGroupLabels': ['C13-CAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Kimiyoshi Sudoh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EPS Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}