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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

NCT00291642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2018-09-11

Study results available
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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

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Cares · UCB (+1 844 599 2273)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-01
Primary Completion
2006-04-01
Completion
2006-04-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291642 on ClinicalTrials.gov