Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
This study is currently recruiting participants.
Verified September 2012 by Ono Pharmaceutical Co. Ltd
Sponsor:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01748344
First received: November 1, 2012
Last updated: December 11, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Cetirizine Drug: High dose ONO-4053 Drug: Low dose ONO-4053 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
Primary Outcome Measures:
- Total Nasal Symptom Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]Itching and ocular discharge monitored daily
- Pharmacokinetics [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]AUE (0-2h, 2-6h and 0-6h)
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: Cetirizine
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748344
Contacts
| Contact: Study Manager | j-osullivan@ono-uk.co.uk |
Locations
| Austria | |
| Vienna Clinical Site | Recruiting |
| Vienna, Austria | |
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Study Director | Ono Pharmaceutical Co. Ltd |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT01748344 History of Changes |
| Other Study ID Numbers: | ONO-4053POE003 |
| Study First Received: | November 1, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Cetirizine |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013