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Completed Phase 4 Interventional

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

ClinicalTrials.gov ID: NCT00637611

Public ClinicalTrials.gov record NCT00637611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo

Study identification

NCT ID
NCT00637611
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sanofi
Industry
Enrollment
1,010 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
15 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2003
Primary completion
Not listed
Completion
Mar 31, 2003
Last update posted
Jan 11, 2011

2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Sanofi-Aventis Bridgewater New Jersey 08807

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00637611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2011 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00637611 live on ClinicalTrials.gov.

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