Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 8:07 PM
Study NCT ID:
NCT02674412
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Buspirone for Functional Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002065', 'term': 'Buspirone'}], 'ancestors': [{'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gabbars@ccf.org', 'phone': '216 444-6523', 'title': 'Scott Gabbard, MD', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Buspirone', 'description': 'Buspirone 10 mg PO TID\n\nBuspirone', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Tablet TID\n\nPlacebo: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buspirone', 'description': 'All participants in the study, while taking Buspirone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants on the study, while taking placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '241.9', 'spread': '771.7', 'groupId': 'OG000'}, {'value': '340.4', 'spread': '761.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in the score from Baseline to 14 days', 'description': 'DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buspirone', 'description': 'All participants in the study, while taking Buspirone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants in the study, while taking placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.1', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '16.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in the score from Baseline to 14 days', 'description': 'A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buspirone', 'description': 'All participants in the study, while taking Buspirone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants in the study, while taking placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '37', 'groupId': 'OG000'}, {'value': '20', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg', 'unitOfMeasure': 'percentage of swallows', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buspirone Then Placebo', 'description': 'Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks'}, {'id': 'FG001', 'title': 'Placebo Then Buspirone', 'description': 'Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants who enrolled in and completed the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis was performed for each subject during two separate periods--once while on Buspirone and once while on Placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-10', 'size': 206918, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-10T15:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2016-02-01', 'resultsFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-10', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry', 'timeFrame': 'Change in the score from Baseline to 14 days', 'description': 'DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.'}], 'secondaryOutcomes': [{'measure': 'Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score', 'timeFrame': 'Change in the score from Baseline to 14 days', 'description': 'A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).'}, {'measure': 'Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.', 'timeFrame': '14 days', 'description': 'A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Functional Dysphagia', 'Ineffective Esophageal Motility']}, 'descriptionModule': {'briefSummary': 'This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.', 'detailedDescription': 'Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry).\n\nOur two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills.\n\nWe hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above\n* Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction\n* Esophageal biopsies negative for eosinophilic esophagitis\n\nExclusion Criteria:\n\n* Pregnant women\n* Prisoners\n* Currently on other serotonin modulating medications'}, 'identificationModule': {'nctId': 'NCT02674412', 'briefTitle': 'Buspirone for Functional Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia', 'orgStudyIdInfo': {'id': 'IRB 15-544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buspirone then Placebo', 'description': 'Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks', 'interventionNames': ['Drug: Buspirone', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then Buspirone', 'description': 'Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.', 'interventionNames': ['Drug: Buspirone', 'Drug: Placebo']}], 'interventions': [{'name': 'Buspirone', 'type': 'DRUG', 'otherNames': ['Buspar'], 'armGroupLabels': ['Buspirone then Placebo', 'Placebo then Buspirone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic', 'armGroupLabels': ['Buspirone then Placebo', 'Placebo then Buspirone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Scott Gabbard, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}