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

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ClinicalTrials.gov Identifier: NCT01748344
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Cetirizine Drug: High dose ONO-4053 Drug: Low dose ONO-4053 Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: Experimental 1
High dose ONO-4053
Drug: High dose ONO-4053
Experimental
Other Name: 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 Name: Experimental 2

Placebo Comparator: Placebo
Placebo
Drug: Placebo
None active




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Total Ocular Symptom Score [ Time Frame: 4 months ]
    Itching and ocular discharge monitored daily

  3. Pharmacokinetics [ Time Frame: Days 1 and 8 ]
    AUE (0-2h, 2-6h and 0-6h)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748344


Locations
Austria
Vienna Clinical Site
Vienna, Austria
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Study Director Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01748344     History of Changes
Other Study ID Numbers: ONO-4053POE003
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: September 2012

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs