Rhinitis, Allergic, PerennialPhase 3NCT00639587
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
A Phase 3 study testing Ketotifen and Cetirizine in people with Rhinitis, Allergic, Perennial, run by UCB Pharma.
Trial summary
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Ketotifen and Cetirizine
- Type of treatment
- Pill or oral medicine
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Mar 2003
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
- severity of nasal symptoms was moderate to severe during the observation period;
- criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.
Who cannot join
- history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
- history of drug hypersensitivity;
- history of convulsive disorder;
- vasomotor rhinitis or eosinophilic rhinitis;
- asthma requiring treatment with adrenocortical hormones;
- concomitant diseases which could impede the efficacy evaluation of the study drug;
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- subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
- pollen allergy;
- malignant neoplasm.
About this study
Official title: A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Ketotifen, Cetirizine
- Keywords
- Cetirizine, Zyrtec
- 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.
KetotifenDrug
Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
CetirizineDrug
Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
Measured: TSS: 2 weeks - Safety: 3 weeks
Secondary outcomes (1)
Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
Measured: T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startAug 2002
- Primary completionMar 2003
- Study completionMar 2003
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.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, +1-877-822-9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639587
- Sponsor's protocol ID
- A00275
- Status last verified
- Sep 2009
- First submitted
- 14 Mar 2008
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
- ClinicalTrials.gov ID
- NCT00639587
- Acronym / sponsor ID
- A00275
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Cetirizine, Zyrtec
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 20 Mar 2008 (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.
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
- severity of nasal symptoms was moderate to severe during the observation period;
- criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.
Key exclusion criteria (9 listed)
- history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
- history of drug hypersensitivity;
- history of convulsive disorder;
- vasomotor rhinitis or eosinophilic rhinitis;
- asthma requiring treatment with adrenocortical hormones;
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 |
|---|---|---|
| KetotifenKetotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks | Drug | – |
| CetirizineCetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks | Drug | – |
Primary outcome
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
Time frame: TSS: 2 weeks - Safety: 3 weeks
1 secondary outcome
Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
Time frame: T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
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 4 Sep 2009.
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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.
UCB Clinical Trial Call Center study director
+1-877-822-9493 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketotifen and Cetirizine in people with Rhinitis, Allergic, Perennial, run by UCB Pharma.
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 3 inclusion and 9 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 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments (time frame: TSS: 2 weeks - Safety: 3 weeks). 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 4 Sep 2009.