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

Sponsor:	Danish Headache Center
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00957983

Purpose

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

Condition	Intervention	Phase
Headache, Migraine	Drug: BGC20-1531	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Dinoprostone

U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

Headache [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

rCBF, blood flow, diameter of STA/RA, HR, BP [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]

Enrollment:	8
Study Start Date:	August 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: BGC20-1531 200mg	Drug: BGC20-1531 oral administration followed by Prostaglandin E2 infusion Other Name: EP-4 receptor antagonist
Placebo Comparator: sugar pill	Drug: BGC20-1531 oral administration followed by Prostaglandin E2 infusion Other Name: EP-4 receptor antagonist
Active Comparator: BGC20-1531 400mg	Drug: BGC20-1531 oral administration followed by Prostaglandin E2 infusion Other Name: EP-4 receptor antagonist

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:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957983

Locations

Denmark
Danish Headache Center
Glostrup, Denmark, 2600

Sponsors and Collaborators

Danish Headache Center

Investigators

Principal Investigator:

Messoud Ashina, MD, PhD

Danish Headache Center

More Information

No publications provided

Responsible Party:	Messoud Ashina, PhD, dr.med, senior consulter, Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00957983 History of Changes
Other Study ID Numbers:	BGC20-1531-04
Study First Received:	August 12, 2009
Last Updated:	January 10, 2011
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012