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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
  Purpose

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


Condition Intervention
Headache
 Drug: Prostaglandin F2alpha
Drug: Isoton sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Danish Headache Center
ClinicalTrials.gov Identifier: NCT01327118     History of Changes
Other Study ID Numbers: DHC-PGF2-2010
Study First Received: March 29, 2011
Last Updated: April 13, 2011
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on May 23, 2013