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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651871

Enrollment

779

Registered

2012-07-27

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist

Brief summary

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.

Interventions

DRUGS-555739 Dose 1

DRUGS-555739 Dose 2

DRUGCetirizine HCl Dose 1

DRUGS-555739 placebo

DRUGCetirizine HCl placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
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)
Assessment of electrocardiogram (ECG) findings	At Week 1 (Screening) and Week 5
Assessment of clinical laboratory parameters	At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Change in average AM/PM Total Ocular Symptom Score	Change from baseline through the 2-week treatment period (Day 2 through Day 15)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026