Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-28 @ 10:52 AM
Study NCT ID:
NCT00209261
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.', 'timeFrame': '6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.', 'timeFrame': '3 weeks'}, {'measure': 'The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.', 'timeFrame': '3 weeks'}, {'measure': 'Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.', 'timeFrame': '3 weeks'}, {'measure': 'Safety comparison between the 2 formulations.', 'timeFrame': '6 weeks'}, {'measure': 'Comparison of compliance between the 2 formulations.', 'timeFrame': '6 weeks'}, {'measure': 'The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.', 'timeFrame': '6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Nocturnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '40728007', 'type': 'DERIVED', 'citation': 'Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.'}, {'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.'}, {'pmid': '23677249', 'type': 'DERIVED', 'citation': 'Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.\n\nTo compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.\n\nTo compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations', 'detailedDescription': 'To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.\n\nTo compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.\n\nTo compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children suffering from primary nocturnal enuresis with no organic pathology.\n* Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).\n* Children with a minimum of 6 wet nights in 2 weeks.\n\nExclusion Criteria:\n\n* Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.\n* Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.\n* Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.\n* Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study'}, 'identificationModule': {'nctId': 'NCT00209261', 'acronym': 'PALAT', 'briefTitle': 'A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)', 'orgStudyIdInfo': {'id': 'FE992026 CS022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: MINIRIN Oral Lyophilisate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Minirin tablet']}], 'interventions': [{'name': 'MINIRIN Oral Lyophilisate', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Minirin tablet', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], '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'}}}}