Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT04996134
Status:
AVAILABLE
Last Update Posted:
2025-02-11
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Domperidone Expanded Access Treatment Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.', 'detailedDescription': "To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female\n2. Age 12 and older\n3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.\n4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.\n5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events\n\nExclusion Criteria:\n\nHistory of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.\n\n1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \\> 450 milliseconds for males, QTc\\>470 milliseconds for females).\n2. Hepatic dysfunction\n3. Renal insufficiency\n4. Clinically significant electrolyte disorders.\n5. Gastrointestinal hemorrhage or obstruction\n6. Presence of a prolactinoma (prolactin-releasing pituitary tumor).\n7. Pregnant or breast feeding female\n8. Known allergy to domperidone'}, 'identificationModule': {'nctId': 'NCT04996134', 'briefTitle': 'Domperidone Expanded Access Treatment Program', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Domperidone Protocol - FDA Expanded Access Program', 'orgStudyIdInfo': {'id': 'IRB00107013'}, 'secondaryIdInfos': [{'id': '17-123 (16-817)', 'type': 'OTHER', 'domain': 'Aurora Baycare Medical Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Domperidone Oral Product', 'type': 'DRUG', 'description': '10-30 mg of oral domperidone administered QID.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54311', 'city': 'Green Bay', 'state': 'Wisconsin', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Devin Spaulding, BS', 'role': 'CONTACT', 'email': 'devin.spaulding@aah.org', 'phone': '920-288-3127'}, {'name': 'John J Bosco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aurora BayCare Medical Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}], 'centralContacts': [{'name': 'Devin Spaulding, BS', 'role': 'CONTACT', 'email': 'devin.spaulding@aah.org', 'phone': '920-288-3127'}], 'overallOfficials': [{'name': 'John Bosco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aurora BayCare Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}