Rhinitis, Allergic, PerennialPhase 3NCT00257595
Perennial Allergic Rhinitis In Pediatric Subjects
A Phase 3 study testing Cetirizine Dry Syrup in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site.
Trial summary
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Cetirizine Dry Syrup
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteLocation not given
- Study dates
- Aug 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Location not given1 site
GSK Investigational Site
About this study
Official title: 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.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Cetirizine Dry Syrup
- Keywords
- Perennial Allergic Rhinitis pediatric
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine Dry SyrupDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Secondary outcomes (1)
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257595
- Sponsor's protocol ID
- 104914
- Status last verified
- May 2013
- First submitted
- 21 Nov 2005
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT00257595
- Acronym / sponsor ID
- 104914
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Perennial Allergic Rhinitis pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 23 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine Dry Syrup | Drug | – |
Primary outcome
safety
1 secondary outcome
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetirizine Dry Syrup in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.