NCT00637611

CompletedPhase 4

Single-Center, Double-Blind, Randomized , Parallel Study Com...

Sanofi Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

M016455A_4149

Study Type

interventional

Actual enrollment (reported)

1,010

Locations

1 country

Sites

1

Timeline

Study Start

February 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2003

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1,010 participants
Study completion date: April 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
April 2003
Actual (reported)
First Submitted
March 10, 2008
Actual (reported)
First Posted
March 18, 2008
Actual (reported)

Last Updated: January 12, 2011
Status Verified: January 2011
Last Update Submitted: January 11, 2011

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.

Interventions

Fexofenadine HClDrug

Also known as: Allegra

Eligibility Criteria

Age15 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects, 15 years of age or older
History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Phyllis Diener
Sanofi
STUDY DIRECTOR

Enrollment

1,010 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 18, 2008

Study Start

February 2003

Date type not reported

This date has not been verified as actual or estimated.

Phase 4

Completed

NCT00502775

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Phase 4Completed

NCT00542607

Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Phase 4Completed

NCT00637884

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

Phase 4Completed

NCT00361439

Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Phase 4Terminated

NCT00295022

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Phase 4Completed

NCT00621959

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

Phase 4Completed

History of having a positive response to antihistamines for symptoms of SAR

Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record

All females must have negative urine pregnancy test at screening visit

Willing and able to adhere to visit schedules and all study requirements

You may not qualify if:

Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
Pregnancy or breast-feeding
History of hypersensitivity to the study medications or to drugs with similar chemical structures
Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Upper or lower respiratory infection within 14 days of the first priming visit
Diagnosis of sinusitis within 30 days of the first priming visit
Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
Treatment with any investigational drug in the last 30 days before study entry
Recent history of drug or alcohol abuse
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Unlikelihood to comply with protocol such as those with uncooperative attitude or the inability to return for follow-up visits or to complete the study
Subjects who were randomized into this trial will not be eligible to participate in another fexofenadine hydrochloride 180 mg vs montelukast sodium 10 mg onset of action study (planned to be conducted in 2003)
Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol

Contact the study team to confirm eligibility.

Study Completion

April 2003

Actual (reported)

Last Updated

January 12, 2011

Record last verified: 2011-01

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00637611
Data provider: ClinicalTrials.gov
Source updated: 2011-01-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:43 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations