Population Pharmacokinetics and Dosage Individualization... | NCT04397913

Studies
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA

NCT04397913

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

May 21, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Patent Ductus Arteriosus

Interventions

Paracetamol
Ibuprofen

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2020Estimated

Primary Completion Date

Jan 30, 2023Estimated

Completion Date

May 6, 2023Estimated

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 20, 2020

First Posted Date

May 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2020

Last Update Posted Date

May 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Name	Class
West China Second University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment(paracetamol or ibuprofen)		Paracetamol and ibuprofen are administered at standard dose for children with PDA.	Drug: Paracetamol Drug: Ibuprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol	Drug	15 mg/kg, q6h	Treatment(paracetamol or ibuprofen)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma drug concentration of paracetamol	To detect the plasma concentration of paracetamol after administration	at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
Plasma drug concentration of ibuprofen	To detect the plasma concentration of ibuprofen after administration	at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
Echocardiography	To measure arterial duct diameter, shunt speed and direction of shunt	Through study completion, an average of 3 days
Cardiac function	To detect brain natriuretic peptide(BNP) and troponin T(cTnT)	Through study completion, an average of 3 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have been diagnosed with PDA;
Age: postnatal age ≤ 28 days;
Paracetamol or ibuprofen used as part of regular treatment;
Paracetamol or ibuprofen was administered orally.

Exclusion Criteria:

Patients who die within the treatment cycle;
Patients with other heart diseases;
Other factors that the researcher considers unsuitable for inclusion.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Neonates with patent ductus arteriosus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Zhao, Ph.D	Contact	053188383308		zhao4wei2@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Second University Hospital	Recruiting	Chengdu	Sichuan	610041	China

Condition Browse Module

MeSH Terms

ID	Term
D004374	Ductus Arteriosus, Patent

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D007052	Ibuprofen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided