CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 418 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Montelukast 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00295022
NCT00295022Phase 4Completed

Double-blind, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)

UCB S.A. - Pharma Sector·interventional·Posted Feb 22, 2006·Updated Sep 11, 2018

In Brief

A Phase 4 clinical trial evaluating Placebo, Montelukast, and 1 other intervention for Rhinitis, Allergic, Seasonal. Completed, enrolled 418 participants across 1 site.

Detailed Summary

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2006
Enrollment StartJul 29, 2006
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.4 years ago

Interventions

Placebodrug

* Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use

Montelukastdrug

* Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use

Levocetirizinedrug

* Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of administration: Oral use