Neurointensive Care Unit
Zurich, Switzerland
Completed
NCT Number: NCT01889290
Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
* 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
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
methylnaltrexone
DrugMethylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
Other names: Relistor
Primary outcomes
-
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
Time frame: 5 days
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Registry information
Official study title
Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
Acronym: RELZH12
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jun 28, 2013
- Registry last updated
- Oct 26, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.