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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Cetirizine HCl Dose 1; Drug: S-555739 Dose 2; Drug: S-555739 Dose 1; Drug: Cetirizine HCl placebo; Drug: S-555739 placebo

• Registration Number: NCT01651871
• Lead Sponsor: Shionogi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-27
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Status Verified: 2018-04
• Disposition First Submitted: 2018-04-26
• Disposition First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Disposition First Posted: 2018-04-27
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 779

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 4	Cetirizine HCl Dose 1	-
Treatment Group 5	Cetirizine HCl placebo	-
Treatment Group 2	S-555739 Dose 2	-
Treatment Group 2	Cetirizine HCl Dose 1	-
Treatment Group 3	Cetirizine HCl placebo	-
Treatment Group 2	S-555739 placebo	-
Treatment Group 3	S-555739 Dose 1	-
Treatment Group 1	S-555739 Dose 1	-
Treatment Group 1	Cetirizine HCl Dose 1	-
Treatment Group 5	S-555739 placebo	-
Treatment Group 4	S-555739 placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 clinical laboratory parameters	At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
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 vital signs	At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Assessment of electrocardiogram (ECG) findings	At Week 1 (Screening) and Week 5