Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT03957668
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
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': 'C000595212', 'term': 'polyethylene glycol 3350'}, {'id': 'D007792', 'term': 'Lactulose'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 269241, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-01T21:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-19', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': '7 days, 14 days', 'description': 'The following adverse events may occur after treatment, thus will be evaluated:\n\n* Headache\n* Dizziness\n* Fatigue\n* Weakness\n* Nausea\n* Dry mouth\n* Abdominal pain / cramping\n* Flatulence\n* Rectal irritation\n* Diarrhea / watery stool'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': '7 days, 14 days'}], 'primaryOutcomes': [{'measure': 'Change of number of bowel movements at 1 week', 'timeFrame': '7 days', 'description': 'An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.'}, {'measure': 'Change of number of bowel movements at 2 weeks', 'timeFrame': '14 days', 'description': 'An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.'}], 'secondaryOutcomes': [{'measure': 'Symptom scores at 1 week', 'timeFrame': '7 days', 'description': '* Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)\n* Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)\n* Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)\n* Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent'}, {'measure': 'Symptom scores at 2 weeks', 'timeFrame': '14 days', 'description': '* Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)\n* Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)\n* Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)\n* Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent'}, {'measure': 'Overall rating of effectiveness at 1 week', 'timeFrame': '7 days', 'description': 'Effective: patients with ≥ 3 bowel movements per 7-day period'}, {'measure': 'Overall rating of effectiveness at 2 weeks', 'timeFrame': '14 days', 'description': 'Effective: patients with ≥ 3 bowel movements per 7-day period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PEG 3350', 'Constipation'], 'conditions': ['Constipation - Functional']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females aged ≥ 18 years.\n2. Body Mass Index (BMI) ≥ 18.5\n3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.\n4. Must have ≤ 2 bowel movements during a 7-day qualification period.\n5. In otherwise good health as judged by a physical examination and laboratory testing.\n6. Not taking medications known to affect bowel function in one week before study.\n7. Willing to participate in the study by signing the informed consent.\n\nExclusion Criteria:\n\n1. Hypersensitive to the study medication.\n2. obstructive ileus.\n3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)'}, 'identificationModule': {'nctId': 'NCT03957668', 'briefTitle': 'Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Fakultas Kedokteran Universitas Indonesia'}, 'officialTitle': 'Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation', 'orgStudyIdInfo': {'id': '19-04-0392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG 3350', 'description': 'The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.', 'interventionNames': ['Drug: PEG 3350']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lactulax', 'description': '15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days', 'interventionNames': ['Drug: Lactulose']}], 'interventions': [{'name': 'PEG 3350', 'type': 'DRUG', 'description': 'PEG 3350 17 g once daily for 14 days', 'armGroupLabels': ['PEG 3350']}, {'name': 'Lactulose', 'type': 'DRUG', 'description': 'Lactulose 10 g once daily for 14 days', 'armGroupLabels': ['Lactulax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10260', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Puskesmas Kelurahan Petamburan', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '10440', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Puskesmas Kelurahan Paseban', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Murdani Abdulah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, 'collaborators': [{'name': 'PT Meiji Indonesia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Murdani Abdullah', 'investigatorAffiliation': 'Fakultas Kedokteran Universitas Indonesia'}}}}