Back to resultsCombination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
S-555739 Dose 1
S-555739 Dose 2
Cetirizine HCl Dose 1
S-555739 placebo
Cetirizine HCl placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Treatment Group 1
Treatment Group 2
Treatment Group 3
Treatment Group 4
Treatment Group 5
Arm Description
Outcomes
Primary Outcome Measures
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
Incidence of adverse events (AEs)
Secondary Outcome Measures
Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)
Change in average AM/PM Total Ocular Symptom Score
Assessment of Quality of Life
Assessment of vital signs
Assessment of clinical laboratory parameters
Assessment of electrocardiogram (ECG) findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651871
Brief Title
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
779 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Title
Treatment Group 3
Arm Type
Experimental
Arm Title
Treatment Group 4
Arm Type
Active Comparator
Arm Title
Treatment Group 5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
S-555739 Dose 1
Intervention Type
Drug
Intervention Name(s)
S-555739 Dose 2
Intervention Type
Drug
Intervention Name(s)
Cetirizine HCl Dose 1
Intervention Type
Drug
Intervention Name(s)
S-555739 placebo
Intervention Type
Drug
Intervention Name(s)
Cetirizine HCl placebo
Primary Outcome Measure Information:
Title
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)
Title
Incidence of adverse events (AEs)
Time Frame
From Screening period to Week 6 (Follow-up)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Assessment of Quality of Life
Time Frame
Change from Week 3 to Week 5
Title
Assessment of vital signs
Time Frame
At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Title
Assessment of clinical laboratory parameters
Time Frame
At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Title
Assessment of electrocardiogram (ECG) findings
Time Frame
At Week 1 (Screening) and Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shionogi Clinical Trials Administrator Clinical Support Help Line
Organizational Affiliation
Shionogi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
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