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
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Pharmacokinetics of methylnaltrexone administered once daily
Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
Other Name: Relistor
- Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) [ Time Frame: 5 days ]
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
|Neurointensive Care Unit|
|Principal Investigator:||Natascia Corti, MD||University Hospital Zurich, Pharmacology and Toxicology|