Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-03 @ 6:55 PM
Study NCT ID:
NCT02970968
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527551', 'term': 'LY686017'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400', 'title': 'Vanda Pharmaceuticals', 'organization': 'Vanda Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Studies are needed to determine the mechanisms by which tradipitant reduces nausea and vomiting, and powered to assess idiopathic and diabetic gastroparesis separately.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'All safety analyses are based on the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 31, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 20, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average Nausea Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-1.53', 'upperLimit': '-0.98'}, {'value': '-0.73', 'groupId': 'OG001', 'lowerLimit': '-1.02', 'upperLimit': '-0.44'}]}]}], 'analyses': [{'pValue': '.0099', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population included any subject randomized into the study who received a dose of study medication and had at least 1 valid postbaseline efficacy measurement while on study medication. The ITT Population comprised 141 subjects.'}, {'type': 'SECONDARY', 'title': 'Weekly % Nausea-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '28.81', 'groupId': 'OG000', 'lowerLimit': '21.09', 'upperLimit': '36.53'}, {'value': '15.00', 'groupId': 'OG001', 'lowerLimit': '6.94', 'upperLimit': '23.07'}]}]}], 'analyses': [{'pValue': '.0160', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have had any nausea over the past 24 hours and if yes, to rate the worst occurrence in the past 24 hours on a Likert scale from 1 (very mild) to 5 (very severe). Change in weekly percentage of nausea-free days from baseline is calculated as weekly average post value minus baseline value. Baseline is defined as the average of all nonmissing values in the screening phase (4 weeks).', 'unitOfMeasure': 'Percentage (%) of nausea-free days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Average Vomiting Frequency, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-0.64', 'upperLimit': '-0.34'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.42', 'upperLimit': '-0.10'}]}]}], 'analyses': [{'pValue': '.039', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have vomited in the past 24 hours and how many times they vomited in the past 24 hours. Change from baseline in the weekly average of daily vomiting frequency is calculated as the weekly average post value minus baseline value of the daily daily vomiting frequency from the GCSDD. Baseline is defined as the average of all non-missing values in the screening phase (4 weeks). A negative change indicates improvement.', 'unitOfMeasure': 'weekly average of daily vomit episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'groupId': 'OG000', 'lowerLimit': '-1.14', 'upperLimit': '-0.73'}, {'value': '-0.58', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '-0.36'}]}]}], 'analyses': [{'pValue': '.0223', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '-0.74'}, {'value': '-0.65', 'groupId': 'OG001', 'lowerLimit': '-0.86', 'upperLimit': '-0.45'}]}]}], 'analyses': [{'pValue': '.0497', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. This questionnaire includes the Gastroparesis Cardinal Symptom Index (GCSI). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value= 5 (very severe). PAGI-SYM Total score is constructed as the average of the six symptom sub-scales and a higher score is indicative of greater symptom severity.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CGI-S, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-1.36', 'upperLimit': '-0.91'}, {'value': '-0.74', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '-0.50'}]}]}], 'analyses': [{'pValue': '.0207', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': "The Clinician Global Impression of Severity (CGI-S) is a 7-point scale on which the clinician rates the severity of the patient's gastroparesis at the time of the assessment and refers to the degree of illness at the time of the visit and during the 2 weeks before the visit. The CGI-S is rated on the following 7-point scale: 1: normal, not at all ill; 2: borderline ill: 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.", 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PGI-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '2.93'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '2.78', 'upperLimit': '3.35'}]}]}], 'analyses': [{'pValue': '.0429', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Patient Global Impression of Change (PGI-C) is a patient reported questionnaire with a 7-point rating scale where the participant rates his/her own improvement in overall symptoms relative to the baseline assessment. Is is rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in Average Nausea Severity; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-1.72', 'upperLimit': '-1.14'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-0.76', 'upperLimit': '-0.07'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'GCSDD, % Nausea-Free Days; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '40.8'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '17.5'}]}]}], 'analyses': [{'pValue': '.0003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis in the past 24 hours on a scale from 0 (no symptoms) to 5 (very severe).', 'unitOfMeasure': 'Percentage (%) of nausea-free days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'GCSDD, Daily Average Vomiting Frequency, Change From Baseline; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'groupId': 'OG000', 'lowerLimit': '-0.89', 'upperLimit': '-0.49'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-0.56', 'upperLimit': '-0.08'}]}]}], 'analyses': [{'pValue': '.023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis in the past 24 hours on a scale from 0 (no symptoms) to 5 (very severe). Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.', 'unitOfMeasure': 'weekly average of daily vomit episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'groupId': 'OG000', 'lowerLimit': '-1.33', 'upperLimit': '-0.87'}, {'value': '-0.60', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '-0.32'}]}]}], 'analyses': [{'pValue': '.0078', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'PAGI-SYM, Change From Baseline; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'groupId': 'OG000', 'lowerLimit': '-1.28', 'upperLimit': '-0.85'}, {'value': '-0.69', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '-0.43'}]}]}], 'analyses': [{'pValue': '.0294', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. This questionnaire includes the Gastroparesis Cardinal Symptom Index (GCSI). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value= 5 (very severe). PAGI-SYM Total score is constructed as the average of the six symptom sub-scales and a higher score is indicative of greater symptom severity.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'CGI-S, Change From Baseline; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-0.99'}, {'value': '-0.79', 'groupId': 'OG001', 'lowerLimit': '-1.08', 'upperLimit': '-0.49'}]}]}], 'analyses': [{'pValue': '.0229', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': "The Clinician Global Impression of Severity (CGI-S) is a 7-point scale on which the clinician rates the severity of the patient's gastroparesis at the time of the assessment and refers to the degree of illness at the time of the visit and during the 2 weeks before the visit. The CGI-S is rates on the following 7-point scale: 1: normal, not at all ill; 2: borderline ill: 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.", 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'PGI-C; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '2.81'}, {'value': '3.24', 'groupId': 'OG001', 'lowerLimit': '2.90', 'upperLimit': '3.59'}]}]}], 'analyses': [{'pValue': '.0018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'The Patient Global Impression of Change (PGI-C) is a patient reported questionnaire with a 7-point rating scale where the participant rates his/her own improvement in overall symptoms relative to the baseline assessment. Is is rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale (change from baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'Nausea Responder Rate (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0013', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as a nausea score of very mild or better (≤1) in average daily nausea severity at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).', 'unitOfMeasure': 'Percentage (%) of nausea responders', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Nausea Responder Rate (%); Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as a nausea score of very mild or better (≤1) in average daily nausea severity at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).', 'unitOfMeasure': 'Percentage (%) of nausea responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'Complete Nausea Responder Rate (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '15.07', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as a nausea score of 0 in at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).', 'unitOfMeasure': 'Percentage (%) of participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Complete Nausea Responder Rate (%); Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '17.24', 'groupId': 'OG000'}, {'value': '4.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0164', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as a nausea score of 0 at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).', 'unitOfMeasure': 'Percentage (%) of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}, {'type': 'POST_HOC', 'title': 'Percentage of Participants With Clinically Meaningful Improvement on Total GCSI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0053', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as 1-point or greater improvement on their GCSI total score from baseline to week 4. The GCSI is a subject reported outcome. Part I consists of the traditional GCSI and severity rating of upper abdominal pain and severity of overall symptoms on a 0 (none) to 5 (very severe) Likert scale. Part II uses a 7-point rating scale for the subject to rate their own improvement relative to baseline. Symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The GCSI subscale scores, nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), and upper abdominal pain (2 items), are calculated by taking the mean of non-missing items in each subscale; the subscale scores vary from 0 (none or absent) to 5 (very severe). The total score is calculated by taking the mean of the three subscales (except upper abdominal pain and overall symptom item).', 'unitOfMeasure': 'Percentage (%)', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Percentage of Participants With Clinically Meaningful Improvement on Total GCSI Score; Baseline Vomiting Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0020', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Defined as 1-point or greater improvement on their GCSI total score from baseline to week 4. The GCSI is a subject reported outcome. Part I consists of the traditional GCSI and severity rating of upper abdominal pain and severity of overall symptoms on a 0 (none) to 5 (very severe) Likert scale. Part II uses a 7-point rating scale for the subject to rate their own improvement relative to baseline. Symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The GCSI subscale scores, nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), and upper abdominal pain (2 items), are calculated by taking the mean of non-missing items in each subscale; the subscale scores vary from 0 (none or absent) to 5 (very severe). The total score is calculated by taking the mean of the three subscales (except upper abdominal pain and overall symptom item).', 'unitOfMeasure': 'Percentage (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tradipitant', 'description': 'oral, 85 mg/day given bid'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'oral, matching placebo given bid'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '13.16', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '13.46', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '13.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Etiology', 'classes': [{'categories': [{'title': 'Idiopathic', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Diabetic', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-26', 'size': 795513, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-05T16:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2016-11-15', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-15', 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Average Nausea Severity', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Weekly % Nausea-Free Days', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have had any nausea over the past 24 hours and if yes, to rate the worst occurrence in the past 24 hours on a Likert scale from 1 (very mild) to 5 (very severe). Change in weekly percentage of nausea-free days from baseline is calculated as weekly average post value minus baseline value. Baseline is defined as the average of all nonmissing values in the screening phase (4 weeks).'}, {'measure': 'Daily Average Vomiting Frequency, Change From Baseline', 'timeFrame': '4 weeks', 'description': 'The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have vomited in the past 24 hours and how many times they vomited in the past 24 hours. Change from baseline in the weekly average of daily vomiting frequency is calculated as the weekly average post value minus baseline value of the daily daily vomiting frequency from the GCSDD. Baseline is defined as the average of all non-missing values in the screening phase (4 weeks). A negative change indicates improvement.'}, {'measure': 'Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline', 'timeFrame': '4 weeks', 'description': 'The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.'}, {'measure': 'PAGI-SYM, Change From Baseline', 'timeFrame': '4 weeks', 'description': 'The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. This questionnaire includes the Gastroparesis Cardinal Symptom Index (GCSI). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value= 5 (very severe). PAGI-SYM Total score is constructed as the average of the six symptom sub-scales and a higher score is indicative of greater symptom severity.'}, {'measure': 'CGI-S, Change From Baseline', 'timeFrame': '4 weeks', 'description': "The Clinician Global Impression of Severity (CGI-S) is a 7-point scale on which the clinician rates the severity of the patient's gastroparesis at the time of the assessment and refers to the degree of illness at the time of the visit and during the 2 weeks before the visit. The CGI-S is rated on the following 7-point scale: 1: normal, not at all ill; 2: borderline ill: 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement."}, {'measure': 'PGI-C', 'timeFrame': '4 weeks', 'description': 'The Patient Global Impression of Change (PGI-C) is a patient reported questionnaire with a 7-point rating scale where the participant rates his/her own improvement in overall symptoms relative to the baseline assessment. Is is rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher scores indicate a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '32693185', 'type': 'DERIVED', 'citation': 'Carlin JL, Lieberman VR, Dahal A, Keefe MS, Xiao C, Birznieks G, Abell TL, Lembo A, Parkman HP, Polymeropoulos MH. Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Jan;160(1):76-87.e4. doi: 10.1053/j.gastro.2020.07.029. Epub 2020 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.', 'detailedDescription': "This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.\n\nThe study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with gastroparesis;\n2. Subjects must agree to the use of contraception\n3. Ability and acceptance to provide written informed consent;\n4. Willing to participate in the pharmacogenomics sample collection;\n5. Willing and able to comply with all study requirements and restrictions\n6. Willing to not participate in any other interventional trial for the duration of their participation.\n\nExclusion Criteria:\n\n1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);\n2. Pregnancy or nursing;\n3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;\n4. Use of another NK1 antagonist or palonosetron;\n5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;\n6. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.'}, 'identificationModule': {'nctId': 'NCT02970968', 'briefTitle': 'Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis', 'orgStudyIdInfo': {'id': 'VP-VLY-686-2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Drug', 'description': 'VLY-686 (Tradipitant) oral capsule for 4 weeks.', 'interventionNames': ['Drug: VLY-686 (Tradipitant)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral capsule for 4 weeks.', 'interventionNames': ['Other: 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