ChildrenPhase 2PPMSNCT02660177
Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old
A Phase 2 study testing Metamizole in people with Children and Pain, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 72 monthsHealthy volunteers can take part
- What is being tested?
- Metamizole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants and children 3-72 months of age at time of inclusion
- Body weight more than 5 kg at time of inclusion
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center, Open-label, Prospective Study to Characterize the Pharmacokinetics of Metamizole and Its Metabolites Following Intravenous Administration in Children Less Than 6 Years Old
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.
Read the detailed description
This is an open-label pharmacokinetics (PK) study. It aims to assess the PK parameters of metamizole and its metabolites following a single IV administration of metamizole (10mg/kg) in children less than 6 years of age.
Thirty-nine children, 3-72 months of age, undergoing elective surgery at the University of Basel Children's Hospital, will receive, on the day of surgical procedure, a single dose of metamizole 10 mg/kg. After this dose, blood and saliva samples will be obtained at predetermined post-dose time points to measure concentrations of metamizole and its metabolites. The maximal duration of subject participation will be 24 hours. Plasma PK parameters (AUC, Cmax, Tmax, t1/2) of each analyte will be derived using noncompartmental methods. A population PK approach will be applied to characterize inter-subject variability and quantify the potential influence of age, sex and body weight on the PK parameters.
There are no published pharmacokinetic studies of metamizole in pediatrics. Furthermore, although Swissmedic provides no dose information for IV administration in infants with a body weight of less than 9 kg, IV is the most frequently used route of administration for direct postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg. Due to the absence of data and the lack of any dosing recommendation for infants with a body weight less than 9 kg, the IV administration of metamizole in infants is "off-label" and inconsistent across hospitals and prescribing paediatricians.
- Being tested
- Metamizole
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizoleDrug
Also called Novalgin
metamizole IV administration
| Study group | Role | What they receive |
|---|---|---|
| metamizole | Experimental | single IV metamizole (10mg/kg) administration Receives: Drug: Metamizole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0- 24 hours
Secondary outcomes (5)
Maximum plasma concentration (Cmax) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Measured: 0- 24 hours
Time to reach Cmax (tmax) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Measured: 0- 24 hours
Terminal elimination rate constant with respective half-life time (t½) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Measured: 0- 24 hours
Incidence of adverse events (AEs)
Measured: 0- 24 hours
Correlation between metamizole and its metabolites in saliva and plasma
Measured: 0- 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederique Rodieux, University Children's Hospital Basel
- Investigators
- Marc Pfister, Professor, Principal investigator, University Children's Hospital BaselRodieux Frederique, Dr. med, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660177
- Sponsor's protocol ID
- 2015-00020
- Other IDs
- 2015
- Acronym
- PPMS
- Status last verified
- May 2018
- First submitted
- 14 Jan 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31388703
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open-label, Prospective Study to Characterize the Pharmacokinetics of Metamizole and Its Metabolites Following Intravenous Administration in Children Less Than 6 Years Old
- ClinicalTrials.gov ID
- NCT02660177
- Acronym / sponsor ID
- PPMS / 2015-00020
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label pharmacokinetics (PK) study. It aims to assess the PK parameters of metamizole and its metabolites following a single IV administration of metamizole (10mg/kg) in children less than 6 years of age.
Thirty-nine children, 3-72 months of age, undergoing elective surgery at the University of Basel Children's Hospital, will receive, on the day of surgical procedure, a single dose of metamizole 10 mg/kg. After this dose, blood and saliva samples will be obtained at predetermined post-dose time points to measure concentrations of metamizole and its metabolites. The maximal duration of subject participation will be 24 hours. Plasma PK parameters (AUC, Cmax, Tmax, t1/2) of each analyte will be derived using noncompartmental methods. A population PK approach will be applied to characterize inter-subject variability and quantify the potential influence of age, sex and body weight on the PK parameters.
There are no published pharmacokinetic studies of metamizole in pediatrics. Furthermore, although Swissmedic provides no dose information for IV administration in infants with a body weight of less than 9 kg, IV is the most frequently used route of administration for direct postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg. Due to the absence of data and the lack of any dosing recommendation for infants with a body weight less than 9 kg, the IV administration of metamizole in infants is "off-label" and inconsistent across hospitals and prescribing paediatricians.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metamizole | Experimental | Drug: Metamizolesingle IV metamizole (10mg/kg) administration |
Who may qualify
- Ages
- 3 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants and children 3-72 months of age at time of inclusion
- Body weight more than 5 kg at time of inclusion
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| MetamizoleAlso: Novalginmetamizole IV administration | Drug | metamizole |
Primary outcome
Area under the plasma concentration-time curves (AUC0-inf, AUC0-24, AUC0-last) for metamizole and its metabolites in plasma and saliva
Time frame: 0- 24 hours
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10 and 24 hours after single IV metamizole dose.
5 secondary outcomes
Maximum plasma concentration (Cmax) for metamizole and its metabolites in plasma and saliva
Time frame: 0- 24 hours
Time to reach Cmax (tmax) for metamizole and its metabolites in plasma and saliva
Time frame: 0- 24 hours
Terminal elimination rate constant with respective half-life time (t½) for metamizole and its metabolites in plasma and saliva
Time frame: 0- 24 hours
Incidence of adverse events (AEs)
Time frame: 0- 24 hours
Correlation between metamizole and its metabolites in saliva and plasma
Time frame: 0- 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Derived from this study: PubMed 31388703Ziesenitz 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.
- Individual participant dataSharing planned: No
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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.
Marc Pfister, Professor principal investigator
University Children's Hospital Basel
Rodieux Frederique, Dr. med principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metamizole in people with Children and Pain, run by University Children's Hospital Basel at 1 site in Switzerland.
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 5 inclusion and 11 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma concentration-time curves (AUC0-inf, AUC0-24, AUC0-last) for metamizole and its metabolites in plasma and saliva (time frame: 0- 24 hours). 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 NCT02660177, which also lists 1 linked publication.
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 30 May 2018.