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

NCT01748344 | Completed Phase 2

• 1 other identifier: ONO-4053POE003
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (3)

• Total Nasal Symptom Score

  4 months

• Total Ocular Symptom Score

  4 months

• Pharmacokinetics

  Days 1 and 8

Study Arms (4)

Experimental 1

EXPERIMENTAL

High dose ONO-4053

Drug: High dose ONO-4053

Cetirizine

ACTIVE COMPARATOR

10mg Cetirizine

Drug: Cetirizine

Experimental 2

EXPERIMENTAL

Low dose ONO-4053

Drug: Low dose ONO-4053

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cetirizine DRUG

10mg tablets

Cetirizine

High dose ONO-4053 DRUG

Experimental

Also known as: Experimental 1

Experimental 1

Low dose ONO-4053 DRUG

Experimental

Also known as: Experimental 2

Experimental 2

Placebo DRUG

None active

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Vienna Clinical Site

Vienna, Austria

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: December 12, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2012-09

Locations

AU (1)