Document Detail


A double-blind, placebo-controlled study of the efficacy and safety of ebastine 20 mg once daily given with and without food in the treatment of seasonal allergic rhinitis.
MedLine Citation:
PMID:  12362923     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The efficacy and safety of ebastine 20 mg once daily given with and without food were compared in patients ages 12 to 70 years with seasonal allergic rhinitis (SAR) caused by mountain cedar allergen. This double-blind, placebo-controlled study was conducted at six centers in Texas. Efficacy and safety analyses were performed on the intent-to-treat population, which comprised 652 patients; 540 patients completed the study. Following 2 weeks' treatment, no significant differences (p > or = 0.91) were found between the ebastine with and without food groups in the percentage change from baseline of daily "reflective" total rhinitis symptom scores (i.e., patients' assessment of severity over the previous 12 h), but both ebastine groups exhibited significantly greater reductions versus patients receiving placebo (p < 0.0001). There were also no significant differences in the percentages of patients experiencing adverse events between the ebastine with and without food groups. Mean steady-state plasma concentrations of ebastine and its active metabolite carebastine were, respectively, 5.5% (ns) and 15.1% (p < 0.05) higher when ebastine was given with food versus its administration without food. Overall, these results indicate that in clinical practice, ebastine does not need to be administered with reference to food.
Authors:
Hampel Frank; Michael Gillen; Shashank S Rohatagi; Janet Lim; George George;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  42     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2002 Oct 
Date Detail:
Created Date:  2002-10-04     Completed Date:  2003-02-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1097-104     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Butyrophenones / blood,  pharmacokinetics,  pharmacology,  therapeutic use*
Child
Double-Blind Method
Female
Food-Drug Interactions*
Histamine H1 Antagonists / pharmacokinetics,  pharmacology,  therapeutic use*
Humans
Male
Middle Aged
Piperidines / blood,  pharmacokinetics,  pharmacology,  therapeutic use*
Rhinitis, Allergic, Seasonal / blood,  drug therapy*
Severity of Illness Index
Treatment Outcome
Chemical
Reg. No./Substance:
0/Butyrophenones; 0/Histamine H1 Antagonists; 0/Piperidines; 90729-42-3/carebastine; 90729-43-4/ebastine

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


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