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Prostaglandin F2alpha in a Human Headache Model

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT01327118
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prostaglandin F2alpha
  • Drug: Isoton sodium chloride
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
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 :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Isoton sodium chloride

Drug: Isoton sodium chloride
intravenous injection
Other Names:
  • placebo

    		•
    Active Comparator: Prostaglandin F2alpha

    Drug: Prostaglandin F2alpha
    intravenous injection
    Other Names:
  • Dinoprost

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [24 h.]

      incidence of headache

    Secondary Outcome Measures

    1. Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) [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.

    2. diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan [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.

    3. mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore® [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.

    4. electrocardiography (ECG) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Headache Center Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Principal Investigator: Troels Wienecke, MD,PhD, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01327118
    Other Study ID Numbers:
    • DHC-PGF2-2010
    First Posted:
    Apr 1, 2011
    Last Update Posted:
    Apr 14, 2011
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Headache
    Dinoprost
    Dinoprost tromethamine

    Study Results

    No Results Posted as of Apr 14, 2011