AllergiesPhase 4NCT00779116
Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)
A Phase 4 study testing Desloratadine and Zyrtec® (cetirizine) in people with Allergies, run by Organon and Co.
Trial summary
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg Chewable Tablet). Subject preference for one product or the other was determined. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergies
- What is being tested?
- Desloratadine and Zyrtec® (cetirizine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject, and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent.
- Subject was to be 6-11 years of age, of either sex and of any race.
- If female, subject was to be premenarcheal.
- Subject was to be willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
- Subject was to be free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
- Subject was to have understood and been able to adhere to the dosing and visit schedules.
Who cannot join
- If female, subject who was pregnant, intended to become pregnant during the study or nursing.
- Subject had used any investigational product within 30 days prior to enrollment.
- Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
- Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
- Subject was participating in any other clinical study(ies).
- Subject was part of the staff or a family member of the staff personnel directly involved with this study.
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- Subject was allergic to or has sensitivity to the study drug or its excipients.
- Subject had a history of allergic reaction to prescription and/or OTC medications and/or food products.
- Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
- Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
About this study
Official title: A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg
Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.
- Conditions
- Allergies
- Being tested
- Desloratadine, Zyrtec® (cetirizine)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called Clarinex, SCH 034117
SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
Zyrtec® (cetirizine)Drug
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
| Study group | Role | What they receive |
|---|---|---|
| RediTab/Zyrtec | Active comparator | Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. Receives: Drug: Desloratadine; Drug: Zyrtec® (cetirizine) |
| Zyrtec/RediTab | Active comparator | Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference. Receives: Drug: Desloratadine; Drug: Zyrtec® (cetirizine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.
Measured: Following the second dose (8-10 minutes after the first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startSep 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergiesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 217 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
- NCT00779116
- Sponsor's protocol ID
- P04574
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tassinari P, Suarez NR, Centeno J, Velasquez JV, Aguirre-Mariscal H, Gonzalezdiaz SN, Jerves AF; LA Desloratadine Study Group. Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years. World Allergy Organ J. 2009 Apr;2(4):42-8. doi: 10.1097/WOX.0b013e31819cdfdb.
PubMed 23282979
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications
- ClinicalTrials.gov ID
- NCT00779116
- Acronym / sponsor ID
- P04574
- Conditions
- Allergies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg
Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RediTab/Zyrtec | Active comparator | Drug: Desloratadine, Drug: Zyrtec® (cetirizine)Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. |
| Zyrtec/RediTab | Active comparator | Drug: Desloratadine, Drug: Zyrtec® (cetirizine)Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject, and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent.
- Subject was to be 6-11 years of age, of either sex and of any race.
- If female, subject was to be premenarcheal.
- Subject was to be willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
- Subject was to be free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
Key exclusion criteria (10 listed)
- If female, subject who was pregnant, intended to become pregnant during the study or nursing.
- Subject had used any investigational product within 30 days prior to enrollment.
- Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
- Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
- Subject was participating in any other clinical study(ies).
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 |
|---|---|---|
| DesloratadineAlso: Clarinex, SCH 034117SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day | Drug | RediTab/Zyrtec, Zyrtec/RediTab |
| Zyrtec® (cetirizine)Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day | Drug | RediTab/Zyrtec, Zyrtec/RediTab |
Primary outcome
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
Time frame: Following the second dose (8-10 minutes after the first dose)
A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23282979Tassinari P, Suarez NR, Centeno J, Velasquez JV, Aguirre-Mariscal H, Gonzalezdiaz SN, Jerves AF; LA Desloratadine Study Group. Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years. World Allergy Organ J. 2009 Apr;2(4):42-8. doi: 10.1097/WOX.0b013e31819cdfdb.
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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 4 study testing Desloratadine and Zyrtec® (cetirizine) in people with Allergies, 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 6 inclusion and 10 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 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. (time frame: Following the second dose (8-10 minutes after the first dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779116, which also lists 1 linked publication.
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 9 Feb 2022.