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NCT01651871 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01651871
Other study ID # 1210D1526
Secondary ID
Status Completed
Phase Phase 2
First received July 17, 2012
Last updated April 26, 2018
Start date July 2012
Est. completion date May 2013

Study information
Verified date April 2018
Source Shionogi Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 779
Est. completion date May 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• S-555739 Dose 1

• S-555739 Dose 2

• Cetirizine HCl Dose 1

• S-555739 placebo

• Cetirizine HCl placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shionogi

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
Primary Incidence of adverse events (AEs) From Screening period to Week 6 (Follow-up)
Secondary 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)
Secondary Change in average AM/PM Total Ocular Symptom Score Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Secondary Assessment of Quality of Life Change from Week 3 to Week 5
Secondary Assessment of vital signs At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Secondary Assessment of clinical laboratory parameters At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Secondary Assessment of electrocardiogram (ECG) findings At Week 1 (Screening) and Week 5
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