NCT02660177

Brief Summary

This study aims to assess the PK parameters of metamizole following a single IV administration of metamizole in children less than 6 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2016

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

January 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

January 14, 2016

Last Update Submit

May 28, 2018

Conditions

ChildrenPainSurgery

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration-time curves (AUC0-inf, AUC0-24, AUC0-last) for metamizole and its metabolites in plasma and saliva

    Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10 and 24 hours after single IV metamizole dose.

    0- 24 hours

Secondary Outcomes (5)

  • Maximum plasma concentration (Cmax) for metamizole and its metabolites in plasma and saliva

    0- 24 hours

  • Time to reach Cmax (tmax) for metamizole and its metabolites in plasma and saliva

    0- 24 hours

  • Terminal elimination rate constant with respective half-life time (t½) for metamizole and its metabolites in plasma and saliva

    0- 24 hours

  • Incidence of adverse events (AEs)

    0- 24 hours

  • Correlation between metamizole and its metabolites in saliva and plasma

    0- 24 hours

Study Arms (1)

metamizole

EXPERIMENTAL

single IV metamizole (10mg/kg) administration

Drug: Metamizole

Interventions

MetamizoleDRUG

metamizole IV administration

Also known as: Novalgin
metamizole

Eligibility Criteria

Age3 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children undergoing elective surgery at University of Basel Children's Hospital (UKBB) with planned administration of intravenous analgesia
  • Patients who require surgical procedures that necessitate at least 24 hours in the hospital
  • Parent/Legal guardian has been informed about the study and has signed Informed Consent Form

You may not qualify if:

  • Infants and children who were born prematurely (before 37 weeks gestation), regardless of corrected gestational age
  • Known kidney or liver disease
  • Known neutropenia, anemia or other hematological disorders
  • Known diagnosis of asthma
  • Ongoing immunosuppression, except corticosteroid treatment, or primary immunodeficiency
  • Treatment with strong inhibitors or inducers of CYP2C19 within 3 months prior to study
  • Treatment with drugs known to induce agranulocytosis within 3 months prior to study
  • Documented previous adverse reaction to metamizole
  • Treatment with metamizole within 30 days prior to screening
  • Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study
  • Family members of investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKBB

Basel, 4056, Switzerland

Location

Related Publications (1)

  • Ziesenitz VC, Rodieux F, Atkinson A, Borter C, Bielicki JA, Haschke M, Duthaler U, Bachmann F, Erb TO, Gurtler N, Holland-Cunz S, van den Anker JN, Gotta V, Pfister M. Dose evaluation of intravenous metamizole (dipyrone) in infants and children: a prospective population pharmacokinetic study. Eur J Clin Pharmacol. 2019 Nov;75(11):1491-1502. doi: 10.1007/s00228-019-02720-2. Epub 2019 Aug 7.

    PMID: 31388703DERIVED

MeSH Terms

Conditions

Pain

Interventions

Dipyrone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marc Pfister, Professor

    University Children's Hospital Basel

    PRINCIPAL INVESTIGATOR

  • Rodieux Frederique, Dr. med

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 21, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)