Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

779 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-05-31

Brief Summary

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The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group 1

Group Type EXPERIMENTAL

S-555739 Dose 1

Intervention Type DRUG

Cetirizine HCl Dose 1

Intervention Type DRUG

Treatment Group 2

Group Type EXPERIMENTAL

S-555739 Dose 2

Intervention Type DRUG

Cetirizine HCl Dose 1

Intervention Type DRUG

S-555739 placebo

Intervention Type DRUG

Treatment Group 3

Group Type EXPERIMENTAL

S-555739 Dose 1

Intervention Type DRUG

Cetirizine HCl placebo

Intervention Type DRUG

Treatment Group 4

Group Type ACTIVE_COMPARATOR

Cetirizine HCl Dose 1

Intervention Type DRUG

S-555739 placebo

Intervention Type DRUG

Treatment Group 5

Group Type PLACEBO_COMPARATOR

S-555739 placebo

Intervention Type DRUG

Cetirizine HCl placebo

Intervention Type DRUG

Interventions

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S-555739 Dose 1

Intervention Type DRUG

S-555739 Dose 2

Intervention Type DRUG

Cetirizine HCl Dose 1

Intervention Type DRUG

S-555739 placebo

Intervention Type DRUG

Cetirizine HCl placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History and diagnosis of seasonal allergic rhinitis by skin prick test
* Have nasal symptom scores as defined by the study protocol
* Able to comply with study procedures

Exclusion Criteria

* Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
* Use of any prohibited concomitant drugs or therapies

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No