Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT03596905
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2018-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-18', 'mcpReleaseN': 8, 'releaseDate': '2025-11-07'}, {'resetDate': '2025-12-08', 'mcpReleaseN': 9, 'releaseDate': '2025-11-24'}, {'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-11-07'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C584575', 'term': 'plecanatide'}]}}, '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': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups', 'timeFrame': '4 Week'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in frequency and severity of abdominal pain/discomfort', 'timeFrame': '4 Week'}, {'measure': 'Change from baseline in frequency of BMs and CSBMs', 'timeFrame': '4 Week'}, {'measure': 'Change from baseline in stool consistency (BSFS or mBSFS-C)', 'timeFrame': '4 Week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome With Constipation']}, 'descriptionModule': {'briefSummary': 'This study of the efficacy and safety of Plecanatide in children 6 to \\<18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)', 'detailedDescription': 'The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to \\<18 years of age with IBS-C.\n\nThe study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\nA patient will be eligible for study participation if he or she meets all of the following criteria:\n\n1. Male or female child aged 6 to \\< 18;\n2. Meets ROME IV criteria for child/adolescent IBS-C\n3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance;\n4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures\n\nEXCLUSION CRITERIA\n\nA patient will be excluded from the study if he or she meets any of the following criteria:\n\n1. The patient has a mental age \\<4 years in the investigator's opinion;\n2. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;\n3. The patient is pregnant or lactating;\n4. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;\n5. The patient has been screened for or participated in another Synergy study in the past;\n6. The patient has a sibling that is currently participating or has participated in another Synergy study."}, 'identificationModule': {'nctId': 'NCT03596905', 'acronym': '(IBS-C)', 'briefTitle': 'Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)', 'orgStudyIdInfo': {'id': 'SP304202-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.5 mg plecanatide', 'description': 'Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'EXPERIMENTAL', 'label': '1.0 mg plecanatide', 'description': 'Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to \\< 18 years old', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'EXPERIMENTAL', 'label': '2.0 mg plecanatide', 'description': 'Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \\< 18 years old', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'EXPERIMENTAL', 'label': '3.0 mg plecanatide', 'description': 'Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \\< 18 years old', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'description': 'Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to \\< 18 years old', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Plecanatide', 'type': 'DRUG', 'otherNames': ['Trulance'], 'description': 'Taken orally daily for 4 weeks', 'armGroupLabels': ['0.5 mg plecanatide', '1.0 mg plecanatide', '2.0 mg plecanatide', '3.0 mg plecanatide']}, {'name': 'Matching placebo', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': 'Taken orally daily for 4 weeks', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92879', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70526', 'city': 'Crowley', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 30.21409, 'lon': -92.37458}}, {'zip': '77061', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}], 'overallOfficials': [{'name': 'John Lahey', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}