Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 10:00 AM
Study NCT ID:
NCT04028492
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-27', 'size': 553555, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-19T13:51', 'hasProtocol': True}, {'date': '2022-10-27', 'size': 302663, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-19T13:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 992}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)', 'timeFrame': '12 weeks', 'description': 'A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary', 'timeFrame': '12 weeks', 'description': 'A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain'}, {'measure': 'Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)', 'timeFrame': '12 weeks', 'description': 'PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).'}, {'measure': 'Change from baseline in Patient Global Impression - Change (PGI-C)', 'timeFrame': '12 weeks', 'description': 'A patient reported outcome measuring a patient\'s rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"'}, {'measure': 'Clinician Global Impression - Severity (CGI-S)', 'timeFrame': '12 weeks', 'description': 'A clinician reported outcome that measures the clinician\'s view of the patient\'s global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."'}, {'measure': 'Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)', 'timeFrame': '12 weeks', 'description': 'Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastroparesis', 'idiopathic', 'diabetic', 'tradipitant', 'nausea', 'vomiting', 'stomach', 'motility', 'functional', 'NK-1 antagonist', 'neurokinin 1 receptor', 'substance p'], 'conditions': ['Idiopathic Gastroparesis', 'Diabetic Gastroparesis', 'Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '38237696', 'type': 'RESULT', 'citation': 'Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.'}], 'seeAlsoLinks': [{'url': 'http://www.gpvandastudy.com', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with gastroparesis\n* Demonstrated delayed gastric emptying\n* Presence of moderate to severe nausea\n* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2\n\nExclusion Criteria:\n\n* Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis\n* A positive test for drugs of abuse at the screening or evaluation visits;\n* Exposure to any investigational medication in the past 60 days\n* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year'}, 'identificationModule': {'nctId': 'NCT04028492', 'briefTitle': 'Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis', 'orgStudyIdInfo': {'id': 'VP-VLY-686-3301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tradipitant', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Tradipitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Open Label Tradipitant', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Open Label Tradipitant']}], 'interventions': [{'name': 'Tradipitant', 'type': 'DRUG', 'description': 'BID', 'armGroupLabels': ['Tradipitant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'BID', 'armGroupLabels': ['Placebo']}, {'name': 'Open Label Tradipitant', 'type': 'DRUG', 'description': 'BID', 'armGroupLabels': ['Open Label Tradipitant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Vanda 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