NCT00291642

A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

Conditions

• Rhinitis
• Allergic
• Seasonal

Interventions

Type	Name	Description
DRUG	Placebo drops	* Pharmaceutical form: Drops for oral administration * Route of administration: Oral use
DRUG	Placebo tablets matching to levocetirizine	* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use
DRUG	Placebo tablets matching to cetirizine	* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use
DRUG	Levocetirizine drops	* Pharmaceutical form: Drops for oral administration * Concentration: 5 mg/ml * Route of administration: Oral use
DRUG	Levocetirizine tablets	* Pharmaceutical form: Tablets for oral administration * Concentration: 5 mg * Route of administration: Oral use
DRUG	Cetirizine drops	* Pharmaceutical form: Drops for oral administration * Concentration: 10 mg/ml * Route of administration: Oral use
DRUG	Cetirizine tablets	* Pharmaceutical form: Tablets for oral administration * Concentration: 10 mg * Route of administration: Oral use

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2006-02-14
• Last updated: 2018-09-11
• Results posted: 2018-07-20

Locations

1 site across 1 country: Canada