Prostaglandin F2alpha in a Human Headache Model
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|ClinicalTrials.gov Identifier: NCT01327118|
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : April 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Prostaglandin F2alpha Drug: Isoton sodium chloride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|Placebo Comparator: Isoton sodium chloride||
Drug: Isoton sodium chloride
Other Name: placebo
|Active Comparator: Prostaglandin F2alpha||
Drug: Prostaglandin F2alpha
Other Name: Dinoprost
- 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 [ Time Frame: 24 h. ]incidence of headache
- Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) [ Time Frame: in-hospital 2 h. ]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.
- diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan [ Time Frame: in-hospital 2 h. ]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.
- mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore® [ Time Frame: in-hospital 2 h. ]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.
- electrocardiography (ECG) [ Time Frame: in-hospital 2 h. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327118
|Danish Headache Center|
|Glostrup, Denmark, 2600|
|Principal Investigator:||Troels Wienecke, MD,PhD||Danish Headache Center|