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

April 26, 2018 updated by: Shionogi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

779

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shionogi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1210D1526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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