RhinitisNCT00704769
Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
An observational study of Rhinitis, run by Organon and Co.
Trial summary
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- Desloratadine (assigned by investigator as part of normal practice)
- Type of treatment
- Pill or oral medicine
- How many people
- 591 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2007
- Phase
- Observational
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, ages 2-11, with a history of perennial allergic rhinitis
Who may be able to join
- Children patients of both sexes aged between 2-11 years, of either gender and any race
- Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
- Minimum score for inclusion: 10
- Capable of complying with the dosing regimen
- Free of any clinically significant disease (other than allergic rhinitis)
- Antihistamine must be justified by investigating doctor
Who cannot join
- Patients with asthma who require chronic use of inhaled or systemic corticosteroids
- History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
- Patients with rhinitis medicamentosa
- History of hypersensitivity to desloratadine or any of its excipients
- Doctor deems unsuitable
About this study
Official title: Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
Read the detailed description
Children, ages 2-11, with a history of perennial allergic rhinitis
- Conditions
- Rhinitis
- Being tested
- Desloratadine (assigned by investigator as part of normal practice)
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine (assigned by investigator as part of normal practice)Drug
Also called SCH 034117
Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children with a history of perennial allergic rhinitis Receives: Drug: Desloratadine (assigned by investigator as part of normal practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
Measured: Minimum of 7 days after initiation of desloratadine
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
Physicians judged the subjects as good, excellent, fair, or poor.
Measured: Minimum of 7 days after initiation of desloratadine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startMay 2005
- Primary completionDec 2007
- Study completionDec 2007
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.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 591 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
- NCT00704769
- Sponsor's protocol ID
- P04299
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients
- ClinicalTrials.gov ID
- NCT00704769
- Acronym / sponsor ID
- P04299
- Conditions
- Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Posted 11 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
Detailed description
Children, ages 2-11, with a history of perennial allergic rhinitis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Desloratadine (assigned by investigator as part of normal practice)Children with a history of perennial allergic rhinitis |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, ages 2-11, with a history of perennial allergic rhinitis
Key inclusion criteria (6 listed)
- Children patients of both sexes aged between 2-11 years, of either gender and any race
- Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
- Minimum score for inclusion: 10
- Capable of complying with the dosing regimen
- Free of any clinically significant disease (other than allergic rhinitis)
Key exclusion criteria (5 listed)
- Patients with asthma who require chronic use of inhaled or systemic corticosteroids
- History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
- Patients with rhinitis medicamentosa
- History of hypersensitivity to desloratadine or any of its excipients
- Doctor deems unsuitable
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 (assigned by investigator as part of normal practice)Also: SCH 034117Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits | Drug | 1 |
Primary outcome
Adverse Events
Time frame: Minimum of 7 days after initiation of desloratadine
An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
Time frame: Minimum of 7 days after initiation of desloratadine
Physicians judged the subjects as good, excellent, fair, or poor.
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.
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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?
An observational study of 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 6 inclusion and 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2009). 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?
Adverse Events (time frame: Minimum of 7 days after initiation of desloratadine). The study lists 2 primary outcomes in all. 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 9 Feb 2022.