Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-03-26 @ 3:22 PM
Study NCT ID:
NCT05144295
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lubiprostone for Functional Constipation in the Under 18 Years Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}, {'id': 'D002214', 'term': 'Capsules'}, {'id': 'D007792', 'term': 'Lactulose'}, {'id': 'D001726', 'term': 'Bisacodyl'}, {'id': 'C005701', 'term': 'picosulfate sodium'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing \\<50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively.\n\nPatients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid.\n\nThe control group will receive the conventional therapy (lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day), or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \\< 12 years or 3 tab/day for \\> 12 years.\n\nBoth arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-12', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'At study week 16.', 'description': 'Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Early spontaneous bowel motions', 'timeFrame': 'First 48 hours after first drug dose.', 'description': 'Number of participants who experienced first SBM within 48 hours after dose initiation.'}, {'measure': 'First dose response time', 'timeFrame': '1st week of treatment', 'description': 'The time between first dose of treatment and the first SBM.'}, {'measure': 'Number of Spontaneous Bowel Motions/Week.', 'timeFrame': 'At study week Week 8, 12.', 'description': 'Number of Spontaneous Bowel Motions/Week.'}, {'measure': 'Responders rate', 'timeFrame': 'At study week Week 8, 12, 16.', 'description': 'Responders rate at week 8, 12, 16.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lubiprostone', 'Functional constipation', 'Adolescent', 'Children', 'Spontaneous Bowel Motions', 'Drug safety'], 'conditions': ['Clinical Efficacy', 'Treatment Efficacy', 'Drug Side Effect']}, 'descriptionModule': {'briefSummary': 'The investigators will enroll subjects 8 - \\< 18 years of age, fulfilling Rome IV criteria for functional constipation.\n\nParticipants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets).\n\nsafety and efficacy will be assessed.', 'detailedDescription': 'The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups.\n\nParticipants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.\n\nThe control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \\< 12 years or 3 tab/day for \\> 12 years.\n\nBoth arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).\n\nParticipants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 8 - \\< 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians.\n* Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation.\n* Patient's daily diary that indicates an average of \\< 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or 2.\n* Patients who completed the study protocol.\n\nExclusion Criteria:\n\n1. If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.\n2. If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.\n3. Patients suffering from Hirschsprung's disease.\n4. Patients experiencing any alarming signs e.g. unexplained significant weight loss.\n5. Untreated fecal impaction at the time of enrollment."}, 'identificationModule': {'nctId': 'NCT05144295', 'briefTitle': 'Lubiprostone for Functional Constipation in the Under 18 Years Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': '0305299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Arm', 'description': '* Patients will receive lubiprostone capsules (Amiprostone 8 and 24 mcg, or Lubicont 8 mcg)\n* Patients weighing \\<50 kg will be given lubiprostone at doses of 8 mcg/8 hours.\n* Patients weighing ≥ 50 kg will be given lubiprostone at doses of 24 mcg BID.\n* Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.', 'interventionNames': ['Drug: Lubiprostone Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Subjects will receive the conventional therapy (one or a combination of the following):\n\n* Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day),\n* Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for \\< 12 years or 3 tab/day for \\> 12 years, or\n* Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day.', 'interventionNames': ['Drug: Lactulose Oral Liquid Product', 'Drug: Bisacodyl 5 MG', 'Drug: Sodium Picosulfate']}], 'interventions': [{'name': 'Lubiprostone Pill', 'type': 'DRUG', 'otherNames': ['Amiprostone 8 mcg caps', 'Amiprostone 24 mcg caps', 'Lubicont 8 mcg caps'], 'description': 'Oral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight.', 'armGroupLabels': ['Investigational Arm']}, {'name': 'Lactulose Oral Liquid Product', 'type': 'DRUG', 'otherNames': ['Lactulose OR Duphalac'], 'description': 'Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)', 'armGroupLabels': ['Control Arm']}, {'name': 'Bisacodyl 5 MG', 'type': 'DRUG', 'otherNames': ['Bisacodyl 5 mg tablets'], 'description': 'Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \\< 12 years or 3 tab/day for \\> 12 years', 'armGroupLabels': ['Control Arm']}, {'name': 'Sodium Picosulfate', 'type': 'DRUG', 'otherNames': ['Bisadyl 0.75% drops'], 'description': 'Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21521', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Main University Hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'zip': '21521', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Sameh A. Lashen, MD (Ph.D.)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Alexandria University - Alexandria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'patient personal and identification data will not be available for sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Sameh A. Lashen', 'investigatorAffiliation': 'Alexandria University'}}}}