Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01327118
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2011-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostaglandin F2alpha in a Human Headache Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015237', 'term': 'Dinoprost'}], 'ancestors': [{'id': 'D011460', 'term': 'Prostaglandins F'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2011-03-30', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache', 'timeFrame': '24 h.', 'description': 'incidence of headache'}], 'secondaryOutcomes': [{'measure': 'Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)', 'timeFrame': 'in-hospital 2 h.', 'description': 'changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.'}, {'measure': 'diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan', 'timeFrame': 'in-hospital 2 h.', 'description': 'changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.'}, {'measure': 'mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®', 'timeFrame': 'in-hospital 2 h.', 'description': 'changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.'}, {'measure': 'electrocardiography (ECG)', 'timeFrame': 'in-hospital 2 h.', 'description': 'changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Primary Headache\n* Headache on the day of the investigation\n* Hypertension\n* Hypotension\n* Pregnant/nursing\n* Daily intake of medication (except oral contraceptives)\n* Cardiovascular or central nervous system (CNS) disease\n* Drug/alcohol abuse\n* Psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01327118', 'briefTitle': 'Prostaglandin F2alpha in a Human Headache Model', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha', 'orgStudyIdInfo': {'id': 'DHC-PGF2-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Isoton sodium chloride', 'interventionNames': ['Drug: Isoton sodium chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prostaglandin F2alpha', 'interventionNames': ['Drug: Prostaglandin F2alpha']}], 'interventions': [{'name': 'Prostaglandin F2alpha', 'type': 'DRUG', 'otherNames': ['Dinoprost'], 'description': 'intravenous injection', 'armGroupLabels': ['Prostaglandin F2alpha']}, {'name': 'Isoton sodium chloride', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'intravenous injection', 'armGroupLabels': ['Isoton sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Troels Wienecke, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Danish Headache Center', 'oldOrganization': 'Danish Headache Center'}}}}