Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-13 @ 11:01 PM
Study NCT ID:
NCT02082457
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2014-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600155', 'term': 'carbamic acid 3-(4-((4-amino-5-chloro-2-methoxybenzoylamino)methyl)piperidin-1-yl)-1-(4-fluorophenyl)propyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal pain intensity & stool frequency responder', 'timeFrame': '12weeks', 'description': 'an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline'}], 'secondaryOutcomes': [{'measure': 'subject global assessment', 'timeFrame': '12 weeks', 'description': 'the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Constipation', 'C-IBS'], 'conditions': ['Irritable Bowel Syndrome', 'Constipation']}, 'descriptionModule': {'briefSummary': 'This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. more than 18 years old\n2. patients met with ROME III criteria for C-type IBS\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* a history of surgery for gastrointestinal tract\n* a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit\n* inflammatory bowel disease or malignant tumor within 5 years of screening visit\n* taking drugs that could have impact on efficacy assessment'}, 'identificationModule': {'nctId': 'NCT02082457', 'acronym': 'YKP', 'briefTitle': 'Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation', 'orgStudyIdInfo': {'id': 'YKP10811_IBS_II_2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.', 'interventionNames': ['Drug: YKP10811 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'YKP10811 10mg', 'description': 'Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.', 'interventionNames': ['Drug: YKP10811 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'YKP10811 20mg', 'description': 'One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.', 'interventionNames': ['Drug: YKP10811 20mg', 'Drug: YKP10811 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'YKP10811 40mg', 'description': 'Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.', 'interventionNames': ['Drug: YKP10811 20mg']}], 'interventions': [{'name': 'YKP10811 5mg', 'type': 'DRUG', 'armGroupLabels': ['YKP10811 10mg']}, {'name': 'YKP10811 20mg', 'type': 'DRUG', 'armGroupLabels': ['YKP10811 20mg', 'YKP10811 40mg']}, {'name': 'YKP10811 placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'YKP10811 20mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Gang Nam Gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Gang Nam Severance Hospital'}], 'overallOfficials': [{'name': 'Hyo jin Park, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gang Nam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}