EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

NCT ID: NCT00957983

Last Updated: 2011-01-11

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

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.

Detailed Description

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Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BGC20-1531 200mg

Group Type ACTIVE_COMPARATOR

BGC20-1531

Intervention Type DRUG

oral administration followed by Prostaglandin E2 infusion

sugar pill

Group Type PLACEBO_COMPARATOR

BGC20-1531

Intervention Type DRUG

oral administration followed by Prostaglandin E2 infusion

BGC20-1531 400mg

Group Type ACTIVE_COMPARATOR

BGC20-1531

Intervention Type DRUG

oral administration followed by Prostaglandin E2 infusion

Interventions

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BGC20-1531

oral administration followed by Prostaglandin E2 infusion

Intervention Type DRUG

Other Intervention Names

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EP-4 receptor antagonist

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Tension headache
* All other primary forms of headache
* Cardiovascular, Central Nervous system (CNS) and autoimmune diseases
* Gastrointestinal disease
* Previous or clinical signs of mental illness or substance abuse.
* Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial
* Pregnancy/nursing
* Daily intake of medication (except oral contraceptives)
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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Messoud Ashina, 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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BGC20-1531-04

Identifier Type: -

Identifier Source: org_study_id

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