Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-04-09 @ 7:46 PM
Study NCT ID:
NCT01855256
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2013-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hyperhidrosis With Oxybutynin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effectiveness of oxybutynin in hyperhidrosis', 'timeFrame': '6 weeks', 'description': 'Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )'}], 'secondaryOutcomes': [{'measure': 'Safety evaluation of treatment in this indication', 'timeFrame': '6 weeks', 'description': 'Number of Participants with Adverse Events will be followed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hyperhidrosis', 'oxybutynin'], 'conditions': ['Hyperhidrosis']}, 'referencesModule': {'references': [{'pmid': '26114588', 'type': 'RESULT', 'citation': 'Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, Sassolas B, Jouan N, Le Ru Y, Abasq-Thomas C, Greco M, Penven K, Roguedas-Contios AM, Dupre-Goetghebeur D, Gouedard C, Misery L, Le Gal G. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Nov;173(5):1163-8. doi: 10.1111/bjd.13973. Epub 2015 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the effectiveness of oxybutynin in hyperhidrosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age greater than 18 years\n* Patient affiliated to social security or beneficiary of such a regime\n* Patient able to consent\n* Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patient who can't be followed\n* Patient participating in another clinical trial\n* Pregnant\n* Woman breastfeeding\n* Hypersensitivity to oxybutynin or any of the excipients\n* Risk of urinary retention related disorders uretroprostatiques\n* Intestinal obstruction\n* Toxic megacolon\n* Intestinal atony\n* Severe Ulcerative Colitis\n* Myasthenia\n* Closure glaucoma the anterior chamber angle or slightly deep"}, 'identificationModule': {'nctId': 'NCT01855256', 'acronym': 'H²O', 'briefTitle': 'Treatment of Hyperhidrosis With Oxybutynin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo', 'orgStudyIdInfo': {'id': 'RB 12.035 H²O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxybutynin', 'description': 'Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.', 'interventionNames': ['Drug: Oxybutynin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxybutynin', 'type': 'DRUG', 'description': 'Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.', 'armGroupLabels': ['oxybutynin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29600', 'city': 'Morlaix', 'state': 'France', 'country': 'France', 'facility': 'CHG de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Hospital, Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29800', 'city': 'Landerneau', 'country': 'France', 'facility': 'CHG Landerneau', 'geoPoint': {'lat': 48.4515, 'lon': -4.25175}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'facility': "Dermatologist'S Office", 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}], 'overallOfficials': [{'name': 'Martine SCHOLLHAMMER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ADBO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}