Status:
COMPLETED
Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
Lead Sponsor:
University of Zurich
Conditions:
Opioid Use, Unspecified With Other Opioid-induced Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
* Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients. * Quantification of methylnaltrexone passage through...
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01889290
Start Date
February 1 2014
End Date
June 1 2016
Last Update
October 26 2016
Active Locations (1)
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1
Neurointensive Care Unit
Zurich, Switzerland