Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05059418
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2021-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002054', 'term': 'Burning Mouth Syndrome'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002998', 'term': 'Clonazepam'}, {'id': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'One clinical examinator for all examinations (baseline examination, outcome assessments), randomization, allocation and drug management by another person,'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'N-of-1 design. Three two-week treatment arms with a one-week wash-out period in between. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months (i.e. this part is not randomized or controlled).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-19', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-19', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Point measurement, will be assessed immediately before start of treatment', 'description': 'Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale'}, {'measure': 'Pain intensity', 'timeFrame': 'Point measurement, will be assessed 10 days after treatment start for each treatment period.', 'description': 'Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale'}, {'measure': 'Pain intensity', 'timeFrame': 'Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)', 'description': 'Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Point measurement, will be assessed immediately before start of treatment', 'description': 'Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Point measurement, will be assessed 10 days after treatment start for each treatment period.', 'description': 'Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)', 'description': 'Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.'}], 'secondaryOutcomes': [{'measure': 'Pain-related disability', 'timeFrame': 'Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.', 'description': 'Pain-related disability from oral mucosal pains. Will be assessed using the subscale "Pain-related Disability" (three numerical rating scales 0 - 10 assessing impact on the oral pain on general, social and work-related activities during the last two weeks) in the Graded Chronic Pain Scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS', 'Chronic pain', 'Pain-related disability', 'Somatosensory changes', 'clonazepam', 'capsaicin', 'oral mucosa'], 'conditions': ['Burning Mouth Syndrome']}, 'descriptionModule': {'briefSummary': 'The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application.\n\nThe second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.', 'detailedDescription': "The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain.\n\nTwenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control.\n\nThe study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience.\n\nThe patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP\n\nExclusion Criteria:\n\n* Fibromyalgia\n* IBS\n* Reflux\n* Recent (\\<3 months) intraoral surgical procedure\n* Ongoing medication with Clonazepam or Capsaicin'}, 'identificationModule': {'nctId': 'NCT05059418', 'acronym': 'BMS', 'briefTitle': 'Burning Mouth Syndrome - New Diagnostic Criteria and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Malmö University'}, 'officialTitle': 'Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment', 'orgStudyIdInfo': {'id': 'BMS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clonazepam', 'description': 'Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day.', 'interventionNames': ['Drug: Clonazepam 0.5 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capsaicin', 'description': 'Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.', 'interventionNames': ['Drug: Capsaicin Topical']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Clonazepam 0.5 MG', 'type': 'DRUG', 'otherNames': ['Iktorivil'], 'description': 'Topical treatment of oral mucosa with lozenge pill', 'armGroupLabels': ['Clonazepam']}, {'name': 'Capsaicin Topical', 'type': 'DRUG', 'otherNames': ['Chili'], 'description': 'Topical treatment of oral mucosa with capsaicin rinse', 'armGroupLabels': ['Capsaicin']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Inget'], 'description': 'Mouth rinse with no capsaicin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Per Alstergren, PhD, Prof', 'role': 'CONTACT', 'email': 'per.alstergren@mau.se', 'phone': '+46406657000'}, {'name': 'Thomas List, PhD, Prof', 'role': 'CONTACT', 'email': 'thomas.list@mau.se', 'phone': '+46406657000'}], 'overallOfficials': [{'name': 'Per Alstergren, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malmö University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malmö University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Pro Dean', 'investigatorFullName': 'Per Alstergren', 'investigatorAffiliation': 'Malmö University'}}}}