Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-29 @ 7:06 PM
Study NCT ID:
NCT00522093
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2007-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TJ-100 in the Treatment of 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-21', 'studyFirstSubmitDate': '2007-08-27', 'studyFirstSubmitQcDate': '2007-08-27', 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events', 'timeFrame': 'baseline (4 weeks)'}, {'measure': 'Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events', 'timeFrame': '6 weeks'}, {'measure': 'Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['constipation'], 'conditions': ['Chronic Constipation']}, 'descriptionModule': {'briefSummary': 'TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week\n* had symptoms of abdominal bloating or discomfort\n\nExclusion Criteria:\n\n* mechanical bowel obstruction\n* clinically systemic disease-induced constipation\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00522093', 'briefTitle': 'Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Showa Inan General Hospital'}, 'orgStudyIdInfo': {'id': 'TJ-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TJ-100', 'type': 'DRUG', 'description': 'TJ-100 2.5g three times per day for 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '399-4191', 'city': 'Komagane', 'country': 'Japan', 'facility': 'Showa Inan General Hospital', 'geoPoint': {'lat': 35.71657, 'lon': 137.93745}}], 'overallOfficials': [{'name': 'Akira Horiuchi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Showa Inan General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa Inan General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tsumura USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Digestive Disease Center', 'investigatorFullName': 'Akira Horiuchi', 'investigatorAffiliation': 'Showa Inan General Hospital'}}}}