Allergic RhinitisPhase 3NCT00794378
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)
A Phase 3 study testing Desloratadine (Clarinex) and Cetirizine (Zyrtec) in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Desloratadine (Clarinex) and Cetirizine (Zyrtec)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2004
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be:
- Between 6 and 11 years of age in good general health
- Premenarcheal if female
Who cannot join
- Subjects who:
- Have known allergies or sensitivities to either of the drug formulations
- Have a medical condition that may interfere with the subject's ability to discriminate between tastes
- Have used any antihistamines within 24 hours prior to dosing
- Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
- Were involved in another clinical or market research study within the past 30 days
About this study
Official title: A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.
Read the detailed description
This study is a cross-over study design.
- Conditions
- Allergic Rhinitis
- Being tested
- Desloratadine (Clarinex), Cetirizine (Zyrtec)
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine (Clarinex)Drug
Also called SCH 034117, Clarinex
Each subject received 5 mL of desloratadine syrup one time
Cetirizine (Zyrtec)Drug
Also called Zyrtec
Each subject received 5 mL of cetirizine syrup
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine and Cetirizine Crossover | Experimental | To compare the preference in taste between desloratadine and cetirizine. Receives: Drug: Desloratadine (Clarinex); Drug: Cetirizine (Zyrtec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
Measured: During the only study visit
Secondary outcomes (2)
Taste flavor preference between bubble-gum, banana-grape, or grape flavors
Measured: During the only study visit
Adverse Events
Measured: During the only study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startNov 2004
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794378
- Sponsor's protocol ID
- P03829
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
- ClinicalTrials.gov ID
- NCT00794378
- Acronym / sponsor ID
- P03829
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 20 Nov 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.
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.
Detailed description
This study is a cross-over study design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desloratadine and Cetirizine Crossover | Experimental | Drug: Desloratadine (Clarinex), Drug: Cetirizine (Zyrtec)To compare the preference in taste between desloratadine and cetirizine. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 6 and 11 years of age in good general health
- Premenarcheal if female
Key exclusion criteria (6 listed)
- Have known allergies or sensitivities to either of the drug formulations
- Have a medical condition that may interfere with the subject's ability to discriminate between tastes
- Have used any antihistamines within 24 hours prior to dosing
- Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
- Were involved in another clinical or market research study within the past 30 days
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 |
|---|---|---|
| Desloratadine (Clarinex)Also: SCH 034117, ClarinexEach subject received 5 mL of desloratadine syrup one time | Drug | Desloratadine and Cetirizine Crossover |
| Cetirizine (Zyrtec)Also: ZyrtecEach subject received 5 mL of cetirizine syrup | Drug | Desloratadine and Cetirizine Crossover |
Primary outcome
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
Time frame: During the only study visit
2 secondary outcomes
Taste flavor preference between bubble-gum, banana-grape, or grape flavors
Time frame: During the only study visit
Adverse Events
Time frame: During the only study visit
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 16 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine (Clarinex) and Cetirizine (Zyrtec) in people with Allergic Rhinitis, run by Organon and Co.
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 6 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 16 Feb 2022. 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?
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face). (time frame: During the only study visit). 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 16 Feb 2022.