Back to resultsPhase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Cetirizine
High dose ONO-4053
Low dose ONO-4053
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
- The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.
Exclusion Criteria:
- The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
- Pregnant or breast-feeding females.
Sites / Locations
- Vienna Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Placebo Comparator
Arm Label
Experimental 1
Cetirizine
Experimental 2
Placebo
Arm Description
High dose ONO-4053
10mg Cetirizine
Low dose ONO-4053
Placebo
Outcomes
Primary Outcome Measures
Total Nasal Symptom Score
To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.
Secondary Outcome Measures
Total Nasal Symptom Score
To investigate the effect of repeat oral doses of ONO-4053 versus Cetirizine on nasal symptoms (Total Nasal Symptom Score) elicited by allergen chamber challenge in subjects with allergic rhinitis.
Total Ocular Symptom Score
Itching and ocular discharge monitored daily
Pharmacokinetics
AUE (0-2h, 2-6h and 0-6h)
Full Information
NCT ID
NCT01748344
First Posted
November 1, 2012
Last Updated
April 14, 2014
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01748344
Brief Title
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
Official Title
A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.
Detailed Description
The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
High dose ONO-4053
Arm Title
Cetirizine
Arm Type
Active Comparator
Arm Description
10mg Cetirizine
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Low dose ONO-4053
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Intervention Description
10mg tablets
Intervention Type
Drug
Intervention Name(s)
High dose ONO-4053
Other Intervention Name(s)
Experimental 1
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Low dose ONO-4053
Other Intervention Name(s)
Experimental 2
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
None active
Primary Outcome Measure Information:
Title
Total Nasal Symptom Score
Description
To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Total Nasal Symptom Score
Description
To investigate the effect of repeat oral doses of ONO-4053 versus Cetirizine on nasal symptoms (Total Nasal Symptom Score) elicited by allergen chamber challenge in subjects with allergic rhinitis.
Time Frame
4 months
Title
Total Ocular Symptom Score
Description
Itching and ocular discharge monitored daily
Time Frame
4 months
Title
Pharmacokinetics
Description
AUE (0-2h, 2-6h and 0-6h)
Time Frame
Days 1 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.
Exclusion Criteria:
The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
Pregnant or breast-feeding females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Vienna Clinical Site
City
Vienna
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
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