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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

August 12, 2009
January 10, 2011
August 2009
February 2010   (final data collection date for primary outcome measure)
Headache [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957983 on ClinicalTrials.gov Archive Site
rCBF, blood flow, diameter of STA/RA, HR, BP [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Headache, Migraine
Drug: BGC20-1531
oral administration followed by Prostaglandin E2 infusion
Other Name: EP-4 receptor antagonist
  • Active Comparator: BGC20-1531 200mg
    Intervention: Drug: BGC20-1531
  • Placebo Comparator: sugar pill
    Intervention: Drug: BGC20-1531
  • Active Comparator: BGC20-1531 400mg
    Intervention: Drug: BGC20-1531
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2010
February 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00957983
BGC20-1531-04
Yes
Messoud Ashina, PhD, dr.med, senior consulter, Danish Headache Center
Danish Headache Center
Not Provided
Principal Investigator: Messoud Ashina, MD, PhD Danish Headache Center
Danish Headache Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP