Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis

April 14, 2014 updated by: Ono Pharmaceutical Co. Ltd

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Vienna Clinical Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
None active
Experimental: Experimental 1
High dose ONO-4053
Drug: High dose ONO-4053
Experimental
Other Names:
  • Experimental 1
Active Comparator: Cetirizine
10mg Cetirizine
Drug: Cetirizine
10mg tablets
Experimental: Experimental 2
Low dose ONO-4053
Drug: Low dose ONO-4053
Experimental
Other Names:
  • Experimental 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Nasal Symptom Score
Time Frame: 4 months
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Nasal Symptom Score
Time Frame: 4 months
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.
4 months
Total Ocular Symptom Score
Time Frame: 4 months
Itching and ocular discharge monitored daily
4 months
Pharmacokinetics
Time Frame: Days 1 and 8
AUE (0-2h, 2-6h and 0-6h)
Days 1 and 8

Collaborators and Investigators

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

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Study Director, Ono Pharmaceutical Co. Ltd

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

November 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4053POE003

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.

Clinical Trials on Seasonal Allergic Rhinitis

Clinical Trials on High dose ONO-4053

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe