NCT01499875

Brief Summary

The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin V in non-infectious children to estimate the optimum dosage regime in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 1, 2014

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

August 18, 2011

Last Update Submit

September 30, 2014

Conditions

Phenoxymethylpenicillin

Keywords

PharmacokineticPharmacodynamicPhenoxymethylpenicillinChildren

Outcome Measures

Primary Outcomes (1)

  • Phenoxymethylpenicillin concentrations

    The data will be presented before June 2013

    up to 7 hours after the penicillin is taken

Study Arms (1)

Phenoxymethylpenicillin

OTHER

It is a descriptive trial to find out about the pharmacokinetics

Drug: Phenoxymethylpenicillin

Interventions

PhenoxymethylpenicillinDRUG

mixture, 25 or 50 mg/kg taken once.

Also known as: Primcillin
Phenoxymethylpenicillin

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Non-infectious Danish children at age 0-10 years who were admitted for a chromium51EDTA clearance test

You may not qualify if:

  • Children with allergy to penicillin and children with a prior known reduced glomerular filtration rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Århus University Hospital

Skejby, Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Penicillin V

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Niels H Birkebæk, PhD

    Department of Pediatrics, Århus University Hospital, Skejby

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

December 26, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

October 1, 2014

Record last verified: 2013-01

Locations

DK(1)