- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374530
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2
July 31, 2007 updated by: Danish Headache Center
Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.
Study Overview
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
-
-
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Glostrup, Denmark, DK-2600
- Danish Headache Center
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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 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: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Headache
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Secondary Outcome Measures
Outcome Measure |
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rCBF, blood flow, diameter of STA/RA, HR, BP
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2006
Study Registration Dates
First Submitted
September 8, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (ESTIMATE)
September 11, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 1, 2007
Last Update Submitted That Met QC Criteria
July 31, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-20060026
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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