Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-24 @ 8:53 AM
Study NCT ID:
NCT00467350
Status:
TERMINATED
Last Update Posted:
2020-11-02
First Post:
2007-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Trial of Enema vs. PEG 3350 for Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C000595212', 'term': 'polyethylene glycol 3350'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D004733', 'term': 'Enema'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmiller@cmh.edu', 'phone': '8162343000', 'title': 'Melissa Miller MD', 'organization': "Children's Mercy Hospitals and Clinics"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'More than half of patients who were approached declined participation. A moderate number of patients (29%) were lost to follow-up.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Enema', 'description': 'milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PEG 3350', 'description': 'PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 4, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'treatment failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With Main Symptom Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enema', 'description': 'milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': 'PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Similar to previous studies, the main outcome measure was the change in the child\'s main symptom. Changes were determined by the question "Has your child\'s main symptom improved, stayed the same or gotten worse?" The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same.', 'otherAnalysisDescription': 'A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 days', 'description': 'On day 5, the number of participants who respond "improved" to the question "Has your child\'s main symptom improved, stayed the same or gotten worse?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enema', 'description': 'milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance'}, {'id': 'FG001', 'title': 'PEG 3350', 'description': 'PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.', 'preAssignmentDetails': 'There were no significant events that occurred after enrollment and before study arm assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enema', 'description': 'Rectal enema containing mixture of milk and molasses\n\nmilk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance'}, {'id': 'BG001', 'title': 'PEG 3350', 'description': 'Medication to be taken orally once each day for three consecutive days\n\nPEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'concern patients in oral cleaout arm had worse outcome', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2007-04-26', 'resultsFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2007-04-27', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-09', 'studyFirstPostDateStruct': {'date': '2007-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With Main Symptom Improvement', 'timeFrame': '5 days', 'description': 'On day 5, the number of participants who respond "improved" to the question "Has your child\'s main symptom improved, stayed the same or gotten worse?"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation', 'treatment', 'fecal impaction', 'pediatric'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.', 'detailedDescription': 'Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.\n\nComparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Constipated children who have one of the following three conditions:\n\n * Fecal impaction (lower quadrant mass or dilated rectum with hard stool),\n * Functional fecal retention (large diameter stools as determined by caregiver \\<twice/week and retentive behaviors, or\n * Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician\n\nExclusion Criteria:\n\n* Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)\n* Patients whose evaluation in the ED includes more than plain radiographs or urinalysis\n* Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)\n* Non-English speaking patients and families\n* Patients with milk allergy\n* Patients with molasses allergy\n* Patients who are pregnant\n* Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery\n* Patients who are admitted to an in-patient unit'}, 'identificationModule': {'nctId': 'NCT00467350', 'briefTitle': 'Comparison Trial of Enema vs. PEG 3350 for Constipation', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation', 'orgStudyIdInfo': {'id': '06-07-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'enema', 'description': 'Rectal enema containing mixture of milk and molasses', 'interventionNames': ['Drug: milk and molasses enema']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG 3350', 'description': 'Medication to be taken orally once each day for three consecutive days', 'interventionNames': ['Drug: PEG 3350']}], 'interventions': [{'name': 'PEG 3350', 'type': 'DRUG', 'otherNames': ['Miralax'], 'description': 'PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance', 'armGroupLabels': ['PEG 3350']}, {'name': 'milk and molasses enema', 'type': 'DRUG', 'otherNames': ['enema'], 'description': 'enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance', 'armGroupLabels': ['enema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Melissa K Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melissa Miller', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}