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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00637884 |
Purpose
This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge will be eligible to enter the treatment phase of the study. Baseline efficacy measures will be obtained prior to the dispensing of study medication during both treatment periods. Cat challenges will be initiated 1.5 hours following treatment with study medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Cat Induced Allergic Rhinitis |
Drug: Fexofenadine HCl |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms |
| Enrollment: | 70 |
| Study Start Date: | November 2003 |
| Study Completion Date: | February 2004 |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00637884 History of Changes |
| Other Study ID Numbers: | M016455A_4148 |
| Study First Received: | March 10, 2008 |
| Last Updated: | January 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Fexofenadine Terfenadine Anti-Allergic Agents Therapeutic Uses |
Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |