Rhinitis, Allergic, SeasonalNCT00761527

Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)

An observational study of Rhinitis, Allergic, Seasonal and Rhinitis, Allergic, Perennial, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 months to 11 years
Conditions the study is for: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
What is being tested?: Desloratadine Syrup
Type of treatment: Pill or oral medicine
How many people: 2,980 participants
Where: No sites listed yet
Study dates: Mar 2008to May 2010
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 6 months to 11 years
All sexes
No healthy volunteers
Child

Study population: A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines

Who may be able to join

Outpatient pediatric participants, male or female, aged 6 months to 11 years
Diagnosis of allergic rhinitis or chronic idiopathic urticaria

Who cannot join

Known hypersensitivity to desloratadine

About this study

Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients

The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.

Read the detailed description

Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Conditions: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
Being tested: Desloratadine Syrup
Medical subject headings: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desloratadine SyrupDrug
Also called Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
Desloratadine (Aerius) Syrup;
Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
- Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
- Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
- Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)

Study groups in NCT00761527
Study group	Role	What they receive
Participants with allergic rhinitis or idiopathic urticaria		Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria. Receives: Drug: Desloratadine Syrup

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Events Reported By Category After 14 Days of Treatment
Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) \& Final Visit (Day 15) \& were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality \& intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Measured: 15 Days
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment
Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) \& Final Visit (Day 15) \& were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality \& intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Measured: 15 Days
Participant Global Tolerability Assessment
The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:
- Excellent
- Very Good
- Good
- Fair
- poor
Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented.
Measured: Day 15

Secondary outcomes (1)

Investigator Assessment of Clinical Efficacy
Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.
Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008May 2010

First posted29 Sep 2008 (estimated)
Study startMar 2008
Primary completionMay 2010
Study completionMay 2010

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 Rhinitis, Allergic, SeasonalStudies 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: Ecologic or community
Time perspective: Prospective
Enrolment: 2,980 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761527
Sponsor's protocol ID: P05634
Status last verified: Feb 2022
First submitted: 25 Sep 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

All Rhinitis, Allergic, Seasonal trials

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: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients
ClinicalTrials.gov ID: NCT00761527
Acronym / sponsor ID: P05634
Conditions: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
Study type: Observational
Recruitment status: Completed
Enrolment: 2,980 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 1 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with allergic rhinitis or idiopathic urticaria	–	Drug: Desloratadine SyrupOutpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria.

Who may qualify

Ages: 6 months to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines

Key inclusion criteria (2 listed)

Outpatient pediatric participants, male or female, aged 6 months to 11 years
Diagnosis of allergic rhinitis or chronic idiopathic urticaria

Key exclusion criteria (1 listed)

Known hypersensitivity to desloratadine

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 SyrupAlso: Aerius, Clarinex, SCH 34117, descarboethoxyloratadineDesloratadine (Aerius) Syrup; Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days: * Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine) * Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine) * Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)	Drug	Participants with allergic rhinitis or idiopathic urticaria

Primary outcome

Number of Adverse Events Reported By Category After 14 Days of Treatment
Time frame: 15 Days
Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) \& Final Visit (Day 15) \& were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality \& intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment
Time frame: 15 Days
Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) \& Final Visit (Day 15) \& were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality \& intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Participant Global Tolerability Assessment
Time frame: Day 15
The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows: * Excellent * Very Good * Good * Fair * poor Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented.

1 secondary outcome

Investigator Assessment of Clinical Efficacy
Time frame: Day 15

Results and safety

Results posted to the registry on 1 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desloratadine (Aerius) Syrup	2,980	2,958

Primary outcome: Number of Adverse Events Reported By Category After 14 Days of Treatment

Time frame: 15 Days. Number. Unit: Adverse Events

Measure	Desloratadine (Aerius) Syrup n = 2978
Total Number of AEs	26
Number of Mild AEs	21
Number of Moderate AEs	4
Number of Severe AEs	1
Number of Treatment-related AEs	20
Number of Mild Treatment-related AEs	19
Number of Moderate Treatment-related AEs	0
Number of Severe Treatment-related AEs	1

Population analysed: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.

Primary outcome: Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment

Time frame: 15 Days. Number. Unit: Participants

Measure	Desloratadine (Aerius) Syrup n = 2978
Number of Participants with AEs	24
Number of Participants with Mild AEs	21
Number of Participants with Moderate AEs	2
Number of Participants with Severe AEs	1
Number of Participants with Treatment-related AEs	20
Number of Participants with AEs - Temporary d/c	1
Number of Participants with AEs - Permanent d/c	2
Number of Participants with AEs - Withdrawal	2

Population analysed: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.

Primary outcome: Participant Global Tolerability Assessment

Time frame: Day 15. Number. Unit: Participants

Measure	Desloratadine (Aerius) Syrup n = 2947
Excellent	1278
Very Good	1339
Good	307
Fair	15
Poor	8

Population analysed: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety Population included all participants who had taken at least one dose of Desloratadine Syrup.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desloratadine (Aerius) Syrup	1 of 2,978 (0%)	0 of 2,978 (0%)	Not reported

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.

Related trials for Rhinitis, Allergic, Seasonal

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

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, Allergic, Seasonal and Rhinitis, Allergic, Perennial, 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 2 inclusion and 1 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 1 Mar 2012). 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 Adverse Events Reported By Category After 14 Days of Treatment (time frame: 15 Days). The study lists 3 primary outcomes in all. 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 NCT00761527.

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.