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OpenTrials
Completed

NCT Number: NCT00574379

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hay Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oklahoma Allergy and Asthma Clinic, Oklahoma City, Oklahoma, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilastine

Drug

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

Placebo

Drug

Placebo tablets twice daily for 14 days

Primary outcomes

  1. Change in nasal symptom scores

    Time frame: 14 days

Secondary outcomes

  1. Change in ocular symptom scores and quality of life scores; standard safety assessments

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Faes Farma, S.A.

Industry

Collaborators

  • Allied Research International
  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 17, 2007
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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