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Prostaglandin F2alpha in a Human Headache Model

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01327118
First received: March 29, 2011
Last updated: April 13, 2011
Last verified: July 2010
History of Changes

March 29, 2011
April 13, 2011
September 2010
December 2010   (final data collection date for primary outcome 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 [ Time Frame: 24 h. ] [ Designated as safety issue: No ]
incidence of headache
Same as current
Complete list of historical versions of study NCT01327118 on ClinicalTrials.gov Archive Site
  • Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) [ Time Frame: in-hospital 2 h. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Prostaglandin F2alpha in a Human Headache Model
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha

The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Headache
  • Drug: Prostaglandin F2alpha
    intravenous injection
    Other Name: Dinoprost
  • Drug: Isoton sodium chloride
    intravenous injection
    Other Name: placebo
  • Placebo Comparator: Isoton sodium chloride
    Intervention: Drug: Isoton sodium chloride
  • Active Comparator: Prostaglandin F2alpha
    Intervention: Drug: Prostaglandin F2alpha
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Primary Headache
  • Headache on the day of the investigation
  • Hypertension
  • Hypotension
  • Pregnant/nursing
  • Daily intake of medication (except oral contraceptives)
  • Cardiovascular or central nervous system (CNS) disease
  • Drug/alcohol abuse
  • Psychiatric disease
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01327118
DHC-PGF2-2010
Yes
Danish Headache Center
Danish Headache Center
Not Provided
Principal Investigator: Troels Wienecke, MD,PhD Danish Headache Center
Danish Headache Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP