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Combination 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
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 64 Years (Adult)All SexesDoes not accept 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

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

    First Posted
    July 17, 2012
    Last Updated
    April 26, 2018
    Sponsor
    Shionogi
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    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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