Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients (RELZH12)

October 25, 2016 updated by: University of Zurich

Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Neurointensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • hospitalisation in the neurointensive care unit
  • deep sedation with sufentanil doses of = 40 mcg/h
  • male or female aged 18 years or older
  • females: negative pregnancy test
  • Ventricular drainage as part of needed therapeutic measures

Exclusion criteria:

  • History of hypersensitivity to methylnaltrexone (Relistor®)
  • confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
  • increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
  • severe hepatic insufficiency (Child-Pugh Class C)
  • renal impairment (glomerular filtration rate < 90 ml/min) with or without renal replacement therapy
  • severe diarrhea despite high opioid dosing
  • participation in another study with an investigational drug within the 30 days preceding and during the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Methylnaltrexone
Pharmacokinetics of methylnaltrexone administered once daily
Drug: Methylnaltrexone
Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
Other Names:
  • Relistor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Natascia Corti, MD, University Hospital Zurich, Pharmacology and Toxicology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELZH12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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