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Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

NCT ID: NCT01889290

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

Brief Summary

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* 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

Detailed Description

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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.

Conditions

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Opioid Use, Unspecified With Other Opioid-induced Disorder

Keywords

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methylnaltrexone opioid-antagonist Obstipation pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylnaltrexone

Pharmacokinetics of methylnaltrexone administered once daily

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

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

Interventions

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Methylnaltrexone

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

Intervention Type DRUG

Other Intervention Names

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Relistor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natascia Corti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Pharmacology and Toxicology

Locations

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Neurointensive Care Unit

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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RELZH12

Identifier Type: -

Identifier Source: org_study_id