Study Of Perennial Allergic Rhinitis In Pediatrics
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00253058
First received: November 11, 2005
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial |
Drug: Cetirizine Dry Syrup |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis- |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- change in the total nasal symptom score (TNSS)
Secondary Outcome Measures:
- - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events
| Estimated Enrollment: | 286 |
| Study Start Date: | July 2005 |
Eligibility| Ages Eligible for Study: | 3 Years to 14 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 spastic disease such as epilepsy
- have a history of drug hypersensitivity
- are pregnant, lactating or possibly pregnant female Children
- are sensitive 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 or 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253058
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253058
Locations
| Spain | |
| GSK Investigational Site | |
| Unknown, Spain | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00253058 History of Changes |
| Other Study ID Numbers: | 104912 |
| Study First Received: | November 11, 2005 |
| Last Updated: | May 3, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by GlaxoSmithKline:
|
Allergic pediatric Rhinitis Perennial |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial 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 |
ClinicalTrials.gov processed this record on September 26, 2016