Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-22 @ 8:54 PM
Study NCT ID:
NCT02961556
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2016-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-20', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period', 'timeFrame': 'Screening; Week 2 of administration period'}], 'secondaryOutcomes': [{'measure': 'Change from the second week of the screening period in the number of SBMs at each week of the administration period', 'timeFrame': 'Screening; up to Week 12 of administration period'}, {'measure': 'Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period', 'timeFrame': 'Screening; up to Week 12 of administration period'}, {'measure': 'Change from the screening period in the number of SBMs at two weeks after the initiation of the administration', 'timeFrame': 'Screening; Week 2'}, {'measure': 'Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration', 'timeFrame': 'Screening; Week 2 of administration period'}, {'measure': 'Number of days until SBM and CSBM', 'timeFrame': 'up to Week 12 of administration period'}, {'measure': 'Change from the second week of the screening period in the total number of SBMs at each week of the administration period', 'timeFrame': 'Screening; up to Week 12 of administration period'}, {'measure': 'Percentage of responders for SBM and CSBM at each week of the administration period', 'timeFrame': 'up to Week 12 of administration period'}, {'measure': 'Stool consistency measured by the Bristol stool form scale', 'timeFrame': 'up to Week 12 of administration period'}, {'measure': 'Usage of rescue medication', 'timeFrame': 'up to Week 12 of administration period'}, {'measure': 'Number of pouches of AJG555 administered', 'timeFrame': 'up to Week 12 of administration period'}, {'measure': 'Duration of administration of AJG555', 'timeFrame': 'up to Week 12 of administration period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AJG555', 'Constipation', 'Phase 3', 'Pediatric participants'], 'conditions': ['Chronic Constipation']}, 'descriptionModule': {'briefSummary': 'This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMain Inclusion Criteria:\n\n* Participants with chronic constipation\n* Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)\n* Gender: N/A\n\nExclusion Criteria:\n\nMain Exclusion Criteria:\n\n* Participants with organic constipation or participants suspected of having organic constipation\n* Participants with symptomatic constipation or participants suspected of having symptomatic constipation\n* Participants with drug-induced constipation or participants suspected of having drug-induced constipation'}, 'identificationModule': {'nctId': 'NCT02961556', 'briefTitle': 'General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation', 'orgStudyIdInfo': {'id': 'AJG555/CT2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AJG555', 'description': 'After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks.', 'interventionNames': ['Drug: AJG555']}], 'interventions': [{'name': 'AJG555', 'type': 'DRUG', 'description': "Participants will receive 1 to 6 sachets daily per participants' age and conditions.", 'armGroupLabels': ['AJG555']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #2', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Bunkyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1'}, {'city': 'Hutyu', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1'}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #2', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #2', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'EA Pharma Trial Site #1', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EA Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}