Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-03 @ 9:16 AM
Study NCT ID:
NCT02538302
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2015-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}, {'id': 'C005419', 'term': 'oxybutynin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-29', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-08-29', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ù‘Frequency of nocturnal enuresis', 'timeFrame': '6 months', 'description': 'Number of participants with nocturnal enuresis'}], 'secondaryOutcomes': [{'measure': 'Frequency of urinary incontinency', 'timeFrame': '6 months', 'description': 'Number of participants with urinary incontinency'}, {'measure': 'Frequency of urgency', 'timeFrame': '6 months', 'description': 'Number of participants with urgency'}, {'measure': 'Frequency of Xerostomia', 'timeFrame': '6 months', 'description': 'Number of participants with Xerostomia'}, {'measure': 'Frequency of Xerophthalmia', 'timeFrame': '6 months', 'description': 'Number of participants with Xerophthalmia'}, {'measure': 'Frequency of Blurred vision', 'timeFrame': '6 months', 'description': 'Number of participants with Blurred vision'}, {'measure': 'Frequency of Dysphagia', 'timeFrame': '6 months', 'description': 'Number of participants with Dysphagia'}, {'measure': 'Frequency of constipation', 'timeFrame': '6 months', 'description': 'Number of participants with constipation'}, {'measure': 'Frequency of Diarrhea', 'timeFrame': '6 months', 'description': 'Number of participants with Diarrhea'}, {'measure': 'Frequency of Headache', 'timeFrame': '6 months', 'description': 'Number of participants with Headache'}, {'measure': 'Frequency of Seizure', 'timeFrame': '6 months', 'description': 'Number of participants with Seizure'}, {'measure': 'Frequency of Epistaxis', 'timeFrame': '6 months', 'description': 'Number of participants with Epistaxis'}, {'measure': 'Frequency of Abdominal pain', 'timeFrame': '6 months', 'description': 'Number of participants with Abdominal pain'}, {'measure': 'Frequency of Vomiting', 'timeFrame': '6 months', 'description': 'Number of participants with Vomiting'}, {'measure': 'Frequency of Ear ache', 'timeFrame': '6 months', 'description': 'Number of participants with Ear ache'}, {'measure': 'Frequency of Rhinitis', 'timeFrame': '6 months', 'description': 'Number of participants with Rhinitis'}, {'measure': 'Frequency of Chest pain', 'timeFrame': '6 months', 'description': 'Number of participants with Chest pain'}, {'measure': 'Frequency of Increase in appetite', 'timeFrame': '6 months', 'description': 'Number of participants with Increase in appetite'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Minirin', 'Oxybutynin', 'Nocturnal enuresis'], 'conditions': ['Nocturnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '27123229', 'type': 'DERIVED', 'citation': 'Ghasemi K, Esteghamati M, Mohammadzadeh M, Zare S. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial. Electron Physician. 2016 Mar 25;8(3):2187-93. doi: 10.19082/2187. eCollection 2016 Mar.'}]}, 'descriptionModule': {'briefSummary': 'Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.', 'detailedDescription': 'Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>5 years old\n* Nocturnal enuresis\n* Candidate for pharmacological treatment\n\nExclusion Criteria:\n\n* Children who their parents did noted filled the informed consent form\n* Impossibility of follow up during the study period\n* History of seizure\n* History of rheumatologic disorders such as sjogren's disease"}, 'identificationModule': {'nctId': 'NCT02538302', 'briefTitle': 'Minirin Versus Oxybutynin for Nocturnal Enuresis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'Minirin Versus Oxybutynin for Nocturnal Enuresis in Children', 'orgStudyIdInfo': {'id': '92.121.505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minirin', 'description': '120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months', 'interventionNames': ['Drug: Minirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxybutynin', 'description': '5 mg Oxybutynin twice a daily for 6 months', 'interventionNames': ['Drug: Oxybutynin']}], 'interventions': [{'name': 'Minirin', 'type': 'DRUG', 'otherNames': ['Desmopressin acetate'], 'description': 'Minirin 5 to 10 mg daily for 6 months', 'armGroupLabels': ['Minirin']}, {'name': 'Oxybutynin', 'type': 'DRUG', 'otherNames': ['Ditropan'], 'description': 'Oxybutynin 5 to 10 mg daily for 6 months', 'armGroupLabels': ['Oxybutynin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79176', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Shahid Mohammadi hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}], 'overallOfficials': [{'name': 'Hamidreza Mahboobi, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hormozgan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hamidreza Mahboobi', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}