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Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

NCT01889290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-10-26

No results posted yet for this study

Summary

* Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
* Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
* Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
* Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
* Trial with medicinal product

Conditions

  • Opioid Use, Unspecified With Other Opioid-induced Disorder

Interventions

DRUG

Methylnaltrexone

Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Natascia Corti, MD · University Hospital Zurich, Pharmacology and Toxicology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889290 on ClinicalTrials.gov