Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-01 @ 7:00 AM
Study NCT ID:
NCT00520104
Status:
UNKNOWN
Last Update Posted:
2008-02-29
First Post:
2007-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-02-27', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-21', 'lastUpdatePostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'multiple'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.', 'detailedDescription': 'To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Patients with Allergic Rhinitis\n\nExclusion Criteria:\n\n* Under age 18'}, 'identificationModule': {'nctId': 'NCT00520104', 'briefTitle': 'Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Javelin Pharmaceuticals'}, 'officialTitle': 'A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg', 'orgStudyIdInfo': {'id': 'KET-PK-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'intranasal ketamine', 'interventionNames': ['Drug: intranasal ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'oxymetazoline plus intranasal ketamine', 'interventionNames': ['Drug: intranasal ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'intranasal steroid plus intranasal ketamine', 'interventionNames': ['Drug: intranasal ketamine']}], 'interventions': [{'name': 'intranasal ketamine', 'type': 'DRUG', 'description': 'drug interaction', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02140', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Javelin Pharmaceuticals', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Javelin Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Javelin Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Javelin Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Javelin Pharmaceuticals', 'oldOrganization': 'Javelin Pharmaceuticals'}}}}