- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00257595
Perennial Allergic Rhinitis In Pediatric Subjects
May 3, 2013 updated by: GlaxoSmithKline
Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 3
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
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- GSK Investigational Site
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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
2 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children with perennial allergic rhinitis.
- Giving informed consent.
- Children with a positive response to specific IgE antibody test.
- Children assessed as positive in the nasal eosinophil count.
- Children whose severity score of nasal symptom is 4 or higher.
Exclusion criteria:
- have a history of drug hypersensitivity.
- are pregnant, lactating or possibly pregnant female children.
- Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
- have vasomotor rhinitis and eosinophilic rhinitis.
- have asthma that requires the treatment with corticosteroid.
- have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
- have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
- have started specific desensitization treatment.
- nonspecific modulation treatment but who have not reached the maintenance level of treatment.
- have received surgical treatment for reduction and modulation of nasal mucosa.
- redintegration therapy of nasal cavity to improve the degree of nasal airway.
- surgical operation to improve rhinorrhea.
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: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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safety
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Secondary Outcome Measures
Outcome Measure |
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Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2005
Study Registration Dates
First Submitted
November 21, 2005
First Submitted That Met QC Criteria
November 22, 2005
First Posted (Estimate)
November 23, 2005
Study Record Updates
Last Update Posted (Estimate)
May 6, 2013
Last Update Submitted That Met QC Criteria
May 3, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
Other Study ID Numbers
- 104914
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.
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Clinical Trials on Cetirizine Dry Syrup
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GlaxoSmithKlineCompletedRhinitis, Allergic, Perennial
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GlaxoSmithKlineCompleted
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Boehringer IngelheimCompletedRhinitis, Allergic, Perennial
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Boehringer IngelheimCompletedDermatitis, Atopic
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SamA Pharmaceutical Co., LtdCompletedPerennial Allergic RhinitisKorea, Republic of
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UCB Biopharma SRLRecruitingHealthy Study ParticipantsJapan
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Boehringer IngelheimCompleted
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Chulalongkorn UniversityUnknown
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Penn State UniversityZarbee's Inc.Completed