Document Detail


Efficacy and safety of eletriptan 20 mg, 40 mg and 80 mg in Japanese migraineurs.
MedLine Citation:
PMID:  12133040     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This prospective multicentre, double-blind, randomized, parallel-group, placebo-controlled trial evaluated the efficacy and safety of a single dose of eletriptan 20 mg, 40 mg and 80 mg in Japanese migraineurs. A total of 402 adult Japanese migraineurs were diagnosed using International Headache Society (IHS) criteria. At 2 h after a single dose, the headache response rates of eletriptan 20 mg, 40 mg, 80 mg and placebo were 64%, 67%, 76% and 51%, respectively, with all doses significantly superior to placebo (P<0.05). Eletriptan had a statistically significant dose response for headache relief and pain-free response at 2 h post-dose (P=0.0011 and P=0.0291, respectively). Most all-causality adverse events were mild and there were no deaths or discontinuations. Saliva samples were used to assess serum eletriptan levels 2 h post-dose. Pharmacokinetic evaluations showed no clinically significant differences between Japanese and Western subjects. Eletriptan was shown to be efficacious, safe, and well tolerated in Japanese migraineurs.
Authors:
Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Cephalalgia : an international journal of headache     Volume:  22     ISSN:  0333-1024     ISO Abbreviation:  Cephalalgia     Publication Date:  2002 Jul 
Date Detail:
Created Date:  2002-07-22     Completed Date:  2003-01-17     Revised Date:  2008-02-11    
Medline Journal Info:
Nlm Unique ID:  8200710     Medline TA:  Cephalalgia     Country:  England    
Other Details:
Languages:  eng     Pagination:  416-23     Citation Subset:  IM    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Chromatography, High Pressure Liquid
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Indoles / administration & dosage,  adverse effects*,  analysis,  pharmacokinetics,  therapeutic use*
Japan
Male
Middle Aged
Migraine Disorders / drug therapy*
Multicenter Studies as Topic
Prospective Studies
Pyrrolidines / administration & dosage,  adverse effects*,  analysis,  pharmacokinetics,  therapeutic use*
Recurrence
Saliva / chemistry
Treatment Outcome
Tryptamines
Chemical
Reg. No./Substance:
0/Indoles; 0/Pyrrolidines; 0/Tryptamines; 0/eletriptan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  A prospective study of the headache phase in 32 migraine with aura patients.
Next Document:  An immunocytochemical investigation of human trigeminal nucleus caudalis: CGRP, substance P and 5-HT...