Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-08 @ 6:07 PM
Study NCT ID:
NCT01592734
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D005244', 'term': 'Fecal Impaction'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D004573', 'term': 'Electrolytes'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '4 weeks of observation', 'description': 'Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card'}, {'measure': 'Efficacy', 'timeFrame': '7 days', 'description': 'Feacal impaction resolution'}], 'secondaryOutcomes': [{'measure': 'Clinical tolerability', 'timeFrame': '4 weeks of observation', 'description': 'Recording of all Adverse Events (AEs) occurred during the study'}, {'measure': 'Acceptability', 'timeFrame': '4 weeks of observation', 'description': 'Palatability and easy of taking the solution evaluated by a 5-points scale'}, {'measure': 'Compliance', 'timeFrame': '4 weeks', 'description': 'Percentage of patients who took more than 80% of the prescribed dose'}, {'measure': 'Efficacy', 'timeFrame': '4 weeks', 'description': 'Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic constipation', 'faecal impaction', 'PEG-only laxative'], 'conditions': ['Constipation', 'Faecal Impaction']}, 'referencesModule': {'references': [{'pmid': '23152962', 'type': 'DERIVED', 'citation': 'Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation', 'detailedDescription': 'Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.\n\nPainful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.\n\nIt is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination\n\nExclusion Criteria:\n\n* children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;\n* Children receiving medication influencing gastrointestinal motility;\n* Children with suspected gastrointestinal obstruction or stenosis'}, 'identificationModule': {'nctId': 'NCT01592734', 'briefTitle': 'Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Policlinico Umberto I'}, 'officialTitle': 'Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative', 'orgStudyIdInfo': {'id': 'PEG-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-only', 'description': 'Polyethylene glycol 4000 only (PEG-only).', 'interventionNames': ['Device: Polyethylene glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG-EL', 'description': 'Polyethylene glycol 3350 with electrolytes (PEG-EL).', 'interventionNames': ['Drug: Polyethylene glycol with electrolytes']}], 'interventions': [{'name': 'Polyethylene glycol with electrolytes', 'type': 'DRUG', 'otherNames': ['Movicol bambini'], 'description': 'Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks.\n\nFaecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days.', 'armGroupLabels': ['PEG-EL']}, {'name': 'Polyethylene glycol', 'type': 'DEVICE', 'otherNames': ['Onligol'], 'description': 'Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children \\> 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks.\n\nFaecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days.', 'armGroupLabels': ['PEG-only']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}, 'collaborators': [{'name': "Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giovanni Di Nardo', 'investigatorAffiliation': 'Azienda Policlinico Umberto I'}}}}