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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
Sponsor:
Information provided by:
Danish Headache Center

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
Headache Drug: Prostaglandin F2alpha Drug: Isoton sodium chloride Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Placebo Comparator: Isoton sodium chloride Drug: Isoton sodium chloride
intravenous injection
Other Name: placebo

Active Comparator: Prostaglandin F2alpha Drug: Prostaglandin F2alpha
intravenous injection
Other Name: Dinoprost




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 [ Time Frame: 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) [ 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.

  2. 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.

  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® [ 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.

  4. electrocardiography (ECG) [ 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Troels Wienecke, MD,PhD Danish Headache Center

Responsible Party: Danish Headache Center
ClinicalTrials.gov Identifier: NCT01327118     History of Changes
Other Study ID Numbers: DHC-PGF2-2010
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dinoprost
Dinoprost tromethamine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Oxytocics