CompletedPhase 2

Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

United States805 participantsStarted 2007-12

Plain-language summary

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

Who can participate

Age range12 Years

SexALL

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Inclusion Criteria: * clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms * documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: * significant medical condition * significant nasal abnormality * significant cardiac condition * recent infection * use of other allergy medication during the study

What they're measuring

Change in nasal symptom scores

Timeframe: 14 days

Trial details

NCT IDNCT00574379

SponsorFaes Farma, S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

View on ClinicalTrials.gov More Seasonal Allergic Rhinitis trials