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

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00957983
First received: August 12, 2009
Last updated: January 10, 2011
Last verified: September 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Dinoprostone
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014