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Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients (RELZH12)

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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

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, AUC0-24h, total clearance, halflife, accumulation ratio, renal clearance) [ Time Frame: 5 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
Official Title  ICMJE Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Use, Unspecified With Other Opioid-induced Disorder
Intervention  ICMJE Drug: Methylnaltrexone
Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
Other Name: Relistor
Study Arms  ICMJE Experimental: Methylnaltrexone
Pharmacokinetics of methylnaltrexone administered once daily
Intervention: Drug: Methylnaltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2013)
10
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889290
Other Study ID Numbers  ICMJE RELZH12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Natascia Corti, MD University Hospital Zurich, Pharmacology and Toxicology
PRS Account University of Zurich
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP