Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-06 @ 4:45 AM
Study NCT ID:
NCT04849559
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400', 'title': 'Vanda Pharmaceuticals', 'organization': 'Vanda Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '9 days', 'description': 'Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.', 'eventGroups': [{'id': 'EG000', 'title': 'Tradipitant', 'description': 'Oral Capsule\n\nTradipitant: Tradipitant Capsule', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral Capsule\n\nPlacebo: Placebo Capsule', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'restless leg syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'Oral Capsule\n\nTradipitant: Tradipitant Capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral Capsule\n\nPlacebo: Placebo Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '178.8', 'groupId': 'OG000', 'lowerLimit': '158.0', 'upperLimit': '217.0'}, {'value': '191.1', 'groupId': 'OG001', 'lowerLimit': '169.2', 'upperLimit': '216.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '9 Days', 'description': 'Fasting Gastric volume', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed subjects'}, {'type': 'PRIMARY', 'title': 'Accommodation Volume as Measured by 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Tradipitant Capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral Capsule\n\nPlacebo: Placebo Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '137.0', 'groupId': 'OG000', 'lowerLimit': '106.8', 'upperLimit': '145.0'}, {'value': '134.0', 'groupId': 'OG001', 'lowerLimit': '125.3', 'upperLimit': '141.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '9 Days', 'description': 'Gastric Emptying Solids, T50%, Min', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tradipitant', 'description': 'Oral Capsule\n\nTradipitant: Tradipitant Capsule'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral Capsule\n\nPlacebo: Placebo Capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tradipitant', 'description': 'Oral Capsule\n\nTradipitant: Tradipitant Capsule'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral Capsule\n\nPlacebo: Placebo Capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '9.61', 'groupId': 'BG000'}, {'value': '34.9', 'spread': '10.70', 'groupId': 'BG001'}, {'value': '33.7', 'spread': '10.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-10', 'size': 609711, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-19T14:46', 'hasProtocol': True}, {'date': '2021-05-10', 'size': 461555, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-19T14:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single center, randomized, double-blind, placebo-controlled study to evaluate the effects of tradipitant on satiation, gastric volume, gastric accommodation and gastric emptying in healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2021-04-13', 'resultsFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-19', 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)', 'timeFrame': '9 Days', 'description': 'Fasting Gastric volume'}, {'measure': 'Accommodation Volume as Measured by SPECT', 'timeFrame': '9 Days', 'description': 'Gastric Accommodation post 300mL Ensure'}, {'measure': 'Satiation Expressed as Volume to Fullness as Measured by Satiation Test', 'timeFrame': '9 Days'}, {'measure': 'Gastric Emptying Half-time of Solids as Measured by Scintigraphy', 'timeFrame': '9 Days', 'description': 'Gastric Emptying Solids, T50%, Min'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tradipitant', 'NK-1 antagonist', 'neurokinin 1 receptor'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '35644931', 'type': 'DERIVED', 'citation': 'Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written consent\n* Body Mass Index (BMI) of 18-35 kg/m2\n* No medical problems or chronic diseases\n\nExclusion Criteria:\n\n* Diagnosis of gastrointestinal diseases\n* Structural or metabolic diseases that affect the GI system\n* A positive test for drugs of abuse at screening'}, 'identificationModule': {'nctId': 'NCT04849559', 'briefTitle': 'Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'VP-VLY-686-1301: A Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'VP-VLY-686-1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tradipitant', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Tradipitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tradipitant', 'type': 'DRUG', 'description': 'Tradipitant Capsule', 'armGroupLabels': ['Tradipitant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Vanda Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanda Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}