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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03059511
Other study ID # PK_Nalbuphin_iv_intranasal
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date March 3, 2017
Est. completion date January 10, 2018

Study information

Verified date December 2021
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events. Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up. Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.


Recruitment information / eligibility

Status Terminated
Enrollment 51
Est. completion date January 10, 2018
Est. primary completion date January 10, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility Inclusion Criteria: - Infants 29 days-3 months - Minimum Body weight 3.0 kg - Indications: septical work up - Parent has been informed about the study and has signed Informed Consent Form Exclusion Criteria: - Infants who were born prematurely (before 37 weeks gestation) - Known kidney or liver disease - Known chronic illness - Documented previous adverse reaction to nalbuphine - Treatment with a depressant drug within 5 days prior to study - Epistaxis, nose trauma (only for the intranasal application) - Barriere of language

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nalbuphine
Opioid Pain Medicine

Locations

Country Name City State
Switzerland Childens Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (Area under the plasma concentration-time) Area under the plasma concentration-time from the first to the last sample One Visit = approximately 6 hours
Primary Pharmacokinetics (Maximum Plasma concentration) Maximum Plasma concentration One Visit = approximately 6 hours
Primary Pharmacokinetics (Time to reach Maximum Plasma concentration) Time to reach Maximum Plasma concentration One Visit = approximately 6 hours
Primary Pharmacokinetics (Half-life time) Half-life time One Visit = approximately 6 hours
Primary Pharmacokinetics (Bioavailability of Nalbuphine intranasal) Bioavailability of Nalbuphine intranasal One Visit = approximately 6 hours
Secondary Effect on pain (Neonatal Infant Pain Score) Effect on pain score: NIPS (Neonatal Infant Pain Score) One Visit = approximately 6 hours
Secondary Adverse Events Safety will be evaluated with summary of Adverse Events One Visit = approximately 6 hours
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