Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-09 @ 3:14 PM
Study NCT ID:
NCT02580734
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002054', 'term': 'Burning Mouth Syndrome'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-25', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction/resolution of symptoms in BMS', 'timeFrame': 'within the first 60 days'}], 'secondaryOutcomes': [{'measure': 'improvement in quality of life', 'timeFrame': 'within the first 60 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['burning mouth syndrome', 'treatment', 'oral chronic pain'], 'conditions': ['Burning Mouth Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).', 'detailedDescription': 'This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome, considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4 weeks wash-out period is applied, between these two periods.\n\nThe capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of melatonin). The primary endpoint is the change in pain intensity at the end of each treatment period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep questionnaires are collected (sf-36, HAM-A, ESS, MOS).\n\nAdverse effects are carefully recorded as well as blood samples, in order to measure serum melatonin levels during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 yrs suffering from burning mouth syndrome\n\nExclusion Criteria:\n\n* epilepsy\n* pregnancy\n* concomitant treatment with melatonin\n* concomitant anticoagulants\n* night time working persons'}, 'identificationModule': {'nctId': 'NCT02580734', 'acronym': 'BMS2013', 'briefTitle': 'Efficacy of Melatonin in Burning Mouth Syndrome (BMS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'BMS2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'tablet without melatonin', 'interventionNames': ['Dietary Supplement: melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'melatonin', 'description': 'tablet with melatonin', 'interventionNames': ['Dietary Supplement: melatonin']}], 'interventions': [{'name': 'melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cross-over randomized clinical trials', 'armGroupLabels': ['melatonin', 'placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Oral Diseases', 'investigatorFullName': 'ANDREA SARDELLA', 'investigatorAffiliation': 'University of Milan'}}}}