Prostaglandin F2alpha in a Human Headache Model

NCT ID: NCT01327118

Last Updated: 2011-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Isoton sodium chloride

Group Type PLACEBO_COMPARATOR

Isoton sodium chloride

Intervention Type DRUG

intravenous injection

Prostaglandin F2alpha

Group Type ACTIVE_COMPARATOR

Prostaglandin F2alpha

Intervention Type DRUG

intravenous injection

Interventions

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Prostaglandin F2alpha

intravenous injection

Intervention Type DRUG

Isoton sodium chloride

intravenous injection

Intervention Type DRUG

Other Intervention Names

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Dinoprost placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Danish Headache Center

Principal Investigators

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Troels Wienecke, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DHC-PGF2-2010

Identifier Type: -

Identifier Source: org_study_id

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