Prostaglandin F2alpha in a Human Headache Model

April 13, 2011 updated by: Danish Headache Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 h.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in-hospital 2 h.
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.
in-hospital 2 h.
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.
in-hospital 2 h.
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.
in-hospital 2 h.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (ESTIMATE)

April 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC-PGF2-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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