Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00230594
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desmopressin Response in the Young
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2005-09-28', 'studyFirstSubmitQcDate': '2005-09-29', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of reducing the number of wet nights in children and adolescents with primary nocturnal enuresis.', 'timeFrame': '14 days of screening plus 54 days of treatment'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of percentage baseline reduction in the number of wet nights.', 'timeFrame': '14 days of screening plus 54 days of treatment'}, {'measure': 'To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of the proportion of full, partial and non-responders.', 'timeFrame': '14 days of screening plus 54 days of treatment'}, {'measure': 'To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.', 'timeFrame': '14 days of screening plus 54 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Nocturnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '32364251', 'type': 'DERIVED', 'citation': 'Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.', 'detailedDescription': 'Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease. Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for V2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder capacity.\n\nA melt tablet formulation offers benefits compared to regular tablets and nasal spray. Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.\n* A minimum of 3 wet nights per week in the 2-week screening period without treatment.\n\nExclusion Criteria:\n\n* Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.\n* Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.\n* Usage of any experimental drug or device during 30 days before study entry.'}, 'identificationModule': {'nctId': 'NCT00230594', 'acronym': 'DRY', 'briefTitle': 'Desmopressin Response in the Young', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Desmopressin Response in the Young: A Double-blind, Randomised, Placebo-controlled, Dose-titration Study With Three Different Doses (120 Mcg, 240 Mcg and 360 Mcg) of Desmopressin Administered as a New Melt Tablet in Children and Adolescents With Primary Nocturnal Enuresis (PNE).', 'orgStudyIdInfo': {'id': 'FE992026, CLN 10.3.26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'desmopressin', 'interventionNames': ['Drug: desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'desmopressin', 'type': 'DRUG', 'otherNames': ['DDAVP'], 'description': 'desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male Health Centres', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'N3C 1Z3', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cambridge Family Medical Centre', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Private Clinic', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L6B 1A1', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Quest Clinical Trials Inc.', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'P1B 4Z2', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Private Clinic', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male Health Centres', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L3T 4X1', 'city': 'Thornhill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Markham Place Med Centre', 'geoPoint': {'lat': 43.80011, 'lon': -79.4163}}, {'zip': 'L1N 8M7', 'city': 'Whitby', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Kids Clinic', 'geoPoint': {'lat': 43.88342, 'lon': -78.93287}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}