Trial Outcomes & Findings for Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539) (NCT NCT00730912)

Last Updated: 2017-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

261 participants

Primary outcome timeframe

After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Pediatrics 3 to 6 Years Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
Overall Study STARTED	53	104	104
Overall Study COMPLETED	53	104	103
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pediatrics 3 to 6 Years Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
Overall Study Discontinued	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatrics 3 to 6 Years n=53 Participants Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years n=104 Participants Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years n=104 Participants Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days	Total n=261 Participants Total of all reporting groups
Age, Customized Between 3-6 years	53 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	53 participants n=4 Participants
Age, Customized Between 7 and 15 years	0 participants n=5 Participants	104 participants n=7 Participants	0 participants n=5 Participants	104 participants n=4 Participants
Age, Customized Between 16 - 64 years	0 participants n=5 Participants	0 participants n=7 Participants	104 participants n=5 Participants	104 participants n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	29 Participants n=7 Participants	68 Participants n=5 Participants	113 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	75 Participants n=7 Participants	36 Participants n=5 Participants	148 Participants n=4 Participants

PRIMARY outcome

Timeframe: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed

Population: 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.

Outcome measures

Outcome measures
Measure	Pediatrics 3 to 6 Years n=53 Participants Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years n=104 Participants Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years n=104 Participants Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) SCH 34117	4.16 ng/mL Standard Deviation 1.26	4.30 ng/mL Standard Deviation 1.63	4.61 ng/mL Standard Deviation 1.41
Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) SCH 45581	2.58 ng/mL Standard Deviation 0.76	2.56 ng/mL Standard Deviation 0.86	2.35 ng/mL Standard Deviation 0.54
Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) SCH 29851	3.04 ng/mL Standard Deviation 1.78	5.54 ng/mL Standard Deviation 3.15	6.48 ng/mL Standard Deviation 3.28

PRIMARY outcome

Timeframe: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pediatrics 3 to 6 Years n=53 Participants Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years n=104 Participants Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years n=104 Participants Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
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	16.77 ng•hr/mL Standard Deviation 14.87	26.13 ng•hr/mL Standard Deviation 22.22	34.68 ng•hr/mL Standard Deviation 37.22
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 34117	52.33 ng•hr/mL Standard Deviation 15.63	59.52 ng•hr/mL Standard Deviation 23.73	68.01 ng•hr/mL Standard Deviation 23.33
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 45581	41.54 ng•hr/mL Standard Deviation 11.43	42.28 ng•hr/mL Standard Deviation 14.40	40.75 ng•hr/mL Standard Deviation 9.92

Adverse Events

Pediatrics 3 to 6 Years

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Pediatrics 7 to 15 Years

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Adults 16 to 64 Years

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pediatrics 3 to 6 Years n=53 participants at risk Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days	Pediatrics 7 to 15 Years n=104 participants at risk Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days	Adults 16 to 64 Years n=104 participants at risk Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
Infections and infestations Acute Tonsillitis	5.7% 3/53 • Number of events 3	0.00% 0/104	0.00% 0/104
Infections and infestations Bronchitis	5.7% 3/53 • Number of events 4	0.96% 1/104 • Number of events 1	0.00% 0/104
Infections and infestations Nasopharyngitis	9.4% 5/53 • Number of events 6	0.96% 1/104 • Number of events 1	8.7% 9/104 • Number of events 11
Infections and infestations Pharyngitis	17.0% 9/53 • Number of events 10	2.9% 3/104 • Number of events 3	1.9% 2/104 • Number of events 2
Investigations White Blood Cell Count Increased	5.7% 3/53 • Number of events 3	0.00% 0/104	1.9% 2/104 • Number of events 2
Nervous system disorders Headache	0.00% 0/53	2.9% 3/104 • Number of events 3	5.8% 6/104 • Number of events 7
Respiratory, thoracic and mediastinal disorders Epistaxis	9.4% 5/53 • Number of events 13	8.7% 9/104 • Number of events 11	0.00% 0/104
Respiratory, thoracic and mediastinal disorders Cough	5.7% 3/53 • Number of events 3	1.9% 2/104 • Number of events 2	0.00% 0/104

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator (sub-investigator) will disclose the results and knowledge obtained through this study after discussion with the Sponsor and approval is obtained from the Sponsor. If the investigator (sub-investigator) is to present the results obtained from this study at a medical conference or medical journal, approval of the Sponsor must be obtained beforehand
Publication restrictions are in place

Restriction type: OTHER