Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

Opioid Use, Unspecified With Other Opioid-induced Disorder Clinical Trial

— RELZH12  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889290
• Other study ID #: RELZH12
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2013
• Last updated: October 25, 2016
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Use, Unspecified With Other Opioid-induced Disorder

Intervention

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

Locations

Country	Name	City	State
Switzerland	Neurointensive Care Unit	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)		5 days	Yes