Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 11:54 AM
Study NCT ID:
NCT06836557
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Safety Study of Tradipitant 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS', 'timeFrame': '12 weeks', 'description': 'AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects.\n\nThe Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides.'}, {'measure': 'Number of participants with changes in vital signs identified as Clinically Notable Abnormal values', 'timeFrame': '12 weeks', 'description': 'Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable.'}, {'measure': 'Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate', 'timeFrame': '12 weeks', 'description': 'Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute'}, {'measure': 'Number of participants with Clinically Notable Abnormal laboratory values', 'timeFrame': '12 weeks', 'description': "Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products."}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis', 'timeFrame': '12 weeks', 'description': 'Efficacy is assessed by the Gastroparesis Core Symptom Daily Diary (GCSDD). The GCSDD is a 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': 'To evaluate the efficacy of tradipitant in global improvement', 'timeFrame': '12 weeks', 'description': 'Efficacy is assessed by the Clinical Global Impression - Severity (CGI-S). The CGI-S is 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."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, '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']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic 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* Pregnancy or nursing\n* Evidence of uncontrolled blood glucose (including HbA1C \\>11% at screening or metabolic crisis in past 60 days)'}, 'identificationModule': {'nctId': 'NCT06836557', 'briefTitle': 'Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Open Label, 3-Month Safety Study with Tradipitant in Patients with Idiopathic or Diabetic Gastroparesis', 'orgStudyIdInfo': {'id': 'VP-VLY-686-3304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Tradipitant', 'description': 'Oral Capsule', 'interventionNames': ['Drug: Tradipitant']}], 'interventions': [{'name': 'Tradipitant', 'type': 'DRUG', 'description': 'BID', 'armGroupLabels': ['Open Label Tradipitant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'role': 'CONTACT', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT', 'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400'}], 'overallOfficials': [{'name': 'Vanda Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanda Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}