Perennial Allergic RhinitisPhase 4NCT00730912

Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)

A Phase 4 study testing loratadine in people with Perennial Allergic Rhinitis, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine. Read more about this study

Who is it for?: Ages 3 to 64 years
Conditions the study is for: Perennial Allergic Rhinitis
What is being tested?: loratadine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 261 participants
Where: No sites listed yet
Study dates: Jun 2008to Dec 2008
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 3 to 64 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:
Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Who cannot join

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator

Show all 9Show fewer

Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration

About this study

Official title: Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients

Conditions: Perennial Allergic Rhinitis
Being tested: loratadine
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.

loratadineDrug
Also called Claritin, SCH 29851
Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks
loratadineDrug
Also called Claritin, SCH 29851
loratadine 10 mg tablet once daily for 4 weeks
loratadineDrug
Also called Claritin, SCH 29851
loratadine 10 mg tablet once daily for 4 weeks

Study groups in NCT00730912
Study group	Role	What they receive
Pediatrics 3 to 6 years	Experimental	Pediatrics 3 to 6 years Receives: Drug: loratadine
Pediatrics 7 to 15 years	Experimental	Pediatrics 7 to 15 years Receives: Drug: loratadine
Adults 16 to 64 years	Experimental	Adults 16 to 64 years Receives: Drug: loratadine

What is being measured

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

Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.
Measured: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed
Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.
Measured: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed

Timeline

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

Jun 2008Dec 2008

First posted8 Aug 2008 (estimated)
Study startJun 2008
Primary completionDec 2008
Study completionDec 2008

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 Perennial Allergic RhinitisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730912
Sponsor's protocol ID: P05539
Status last verified: Mar 2017
First submitted: 6 Aug 2008
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

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

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

All Perennial Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients
ClinicalTrials.gov ID: NCT00730912
Acronym / sponsor ID: P05539
Conditions: Perennial Allergic Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 8 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pediatrics 3 to 6 years	Experimental	Drug: loratadinePediatrics 3 to 6 years
Pediatrics 7 to 15 years	Experimental	Drug: loratadinePediatrics 7 to 15 years
Adults 16 to 64 years	Experimental	Drug: loratadineAdults 16 to 64 years

Who may qualify

Ages: 3 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:
Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.

Key exclusion criteria (9 listed)

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 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
loratadineAlso: Claritin, SCH 29851Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks	Drug	Pediatrics 3 to 6 years
loratadineAlso: Claritin, SCH 29851loratadine 10 mg tablet once daily for 4 weeks	Drug	Pediatrics 7 to 15 years
loratadineAlso: Claritin, SCH 29851loratadine 10 mg tablet once daily for 4 weeks	Drug	Adults 16 to 64 years

Primary outcome

Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)
Time frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.
Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)
Time frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.

Results and safety

Results posted to the registry on 5 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatrics 3 to 6 Years	53	53
Pediatrics 7 to 15 Years	104	104
Adults 16 to 64 Years	104	103

Primary outcome: Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)

Time frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed. Mean (Standard Deviation). Unit: ng/mL

Measure	Pediatrics 3 to 6 Years n = 53	Pediatrics 7 to 15 Years n = 104	Adults 16 to 64 Years n = 104
SCH 29851	3.04 (1.78)	5.54 (3.15)	6.48 (3.28)
SCH 34117	4.16 (1.26)	4.30 (1.63)	4.61 (1.41)
SCH 45581	2.58 (0.76)	2.56 (0.86)	2.35 (0.54)

Population analysed: Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.

Primary outcome: Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)

Time frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed. Mean (Standard Deviation). Unit: ng•hr/mL

Measure	Pediatrics 3 to 6 Years n = 53	Pediatrics 7 to 15 Years n = 104	Adults 16 to 64 Years n = 104
SCH 29851	16.77 (14.87)	26.13 (22.22)	34.68 (37.22)
SCH 34117	52.33 (15.63)	59.52 (23.73)	68.01 (23.33)
SCH 45581	41.54 (11.43)	42.28 (14.40)	40.75 (9.92)

Population analysed: Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatrics 3 to 6 Years	0 of 53 (0%)	23 of 53 (43.4%)	Not reported
Pediatrics 7 to 15 Years	0 of 104 (0%)	17 of 104 (16.3%)	Not reported
Adults 16 to 64 Years	0 of 104 (0%)	17 of 104 (16.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Perennial Allergic Rhinitis

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

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 loratadine in people with Perennial Allergic Rhinitis, run by Merck Sharp & Dohme LLC.

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 7 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 13 Apr 2017. 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?

Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) (time frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed). 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?

On the ClinicalTrials.gov record for NCT00730912.

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 13 Apr 2017.