Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT01684969
Status:
WITHDRAWN
Last Update Posted:
2016-03-17
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence of Haloperidol Absorption After Topical Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of accrual and funding is about to expire.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.', 'timeFrame': 'baseline to 240 minutes after administration.', 'description': 'Measuring either the presence of absence of haloperidol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nausea', 'vomiting', 'gastrointestinal symptoms', 'palliative care'], 'conditions': ['Nausea', 'Vomiting']}, 'descriptionModule': {'briefSummary': 'This will be a blinded study to compare the absorption of topical haloperidol with placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age: patient must be 18 years or older and less than 70 years of age.\n* Provision of informed consent\n* No previous adverse reaction to haloperidol\n* No current use of haloperidol\n* Good health\n* No alcohol within 24 hours of the study\n* No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.\n* Normal neurologic exam\n\nExclusionary Criteria\n\n* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study\n* Recent cerebral trauma\n* Study will exclude women who are pregnant and/or nursing\n* Women who are of child bearing potential must have a negative urine pregnancy test.\n* History of seizures\n* Taking medications that can interact with haloperidol\n* Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT01684969', 'briefTitle': 'Evidence of Haloperidol Absorption After Topical Administration', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Topical Haloperidol: Evidence of Absorption After Topical Administration', 'orgStudyIdInfo': {'id': '11-005661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous haloperidol', 'description': 'intravenous haloperidol pharmacokinetics', 'interventionNames': ['Drug: Haloperidol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Haloperidol', 'type': 'DRUG', 'description': '0.5 mg iv x one dose', 'armGroupLabels': ['intravenous haloperidol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.5 mg iv , one dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eric Prommer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eric E. Prommer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, College of Medicine', 'investigatorFullName': 'Eric E. Prommer', 'investigatorAffiliation': 'Mayo Clinic'}}}}