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Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients (RELZH12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889290
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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

Condition or disease Intervention/treatment Phase
Opioid Use, Unspecified With Other Opioid-induced Disorder Drug: Methylnaltrexone Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: Relistor




Primary Outcome Measures :
  1. Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889290


Locations
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Switzerland
Neurointensive Care Unit
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Natascia Corti, MD University Hospital Zurich, Pharmacology and Toxicology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01889290    
Other Study ID Numbers: RELZH12
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by University of Zurich:
methylnaltrexone
opioid-antagonist
Obstipation
pharmacokinetics
Additional relevant MeSH terms:
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Methylnaltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents