Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 6:56 PM
Study NCT ID:
NCT01670669
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prucalopride in Paediatric Subjects, With Functional Faecal Retention
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'description': 'Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.\n\nEfficacy: reporting of bowel movements and its characteristics in a diary.'}, {'measure': 'Efficacy', 'description': 'Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '23535761', 'type': 'DERIVED', 'citation': 'Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.\n\nHypothesis:\n\nPharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.', 'detailedDescription': "This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.\n\nEvaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.\n\nThe initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day."}, 'eligibilityModule': {'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject completed the PRU-USA-12 pharmacokinetic trial\n* Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)\n* Written informed consent, signed by the subject\'s legal guardian and by the investigator\n* Subject assent documented in the form of a note-to-file in the subject\'s source documentation\n\nExclusion Criteria:\n\n• No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01670669', 'briefTitle': 'Prucalopride in Paediatric Subjects, With Functional Faecal Retention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Movetis'}, 'officialTitle': 'An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.', 'orgStudyIdInfo': {'id': 'PRU-USA-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prucalopride', 'description': '0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution', 'interventionNames': ['Drug: prucalopride']}], 'interventions': [{'name': 'prucalopride', 'type': 'DRUG', 'description': '0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution', 'armGroupLabels': ['prucalopride']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Harald Winter, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital for Children, Boston, Massachusetts, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Movetis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}