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

Study Overview
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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.

Official Title
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A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: S-555739 Dose 1
* Drug: S-555739 Dose 2
* Drug: Cetirizine HCl Dose 1
* Drug: S-555739 placebo
* Drug: Cetirizine HCl placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br> | Drug: S-555739 Dose 1<br> <br> Drug: Cetirizine HCl Dose 1<br> <br> |
| Experimental: Treatment Group 2<br> | Drug: S-555739 Dose 2<br> <br> Drug: Cetirizine HCl Dose 1<br> <br> Drug: S-555739 placebo<br> <br> |
| Experimental: Treatment Group 3<br> | Drug: S-555739 Dose 1<br> <br> Drug: Cetirizine HCl placebo<br> <br> |
| Active Comparator: Treatment Group 4<br> | Drug: Cetirizine HCl Dose 1<br> <br> Drug: S-555739 placebo<br> <br> |
| Placebo Comparator: Treatment Group 5<br> | Drug: S-555739 placebo<br> <br> Drug: Cetirizine HCl placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS) |  | Change from baseline through the 2-week treatment period (Day 2 through Day 15) | 
| Incidence of adverse events (AEs) |  | From Screening period to Week 6 (Follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS) |  | Change from baseline through the 2-week treatment period (Day 2 through Day 15) | 
| Change in average AM/PM Total Ocular Symptom Score |  | Change from baseline through the 2-week treatment period (Day 2 through Day 15) | 
| Assessment of Quality of Life |  | Change from Week 3 to Week 5 | 
| Assessment of vital signs |  | At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5 | 
| Assessment of clinical laboratory parameters |  | At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up) | 
| Assessment of electrocardiogram (ECG) findings |  | At Week 1 (Screening) and Week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist