Quantification of Drugs and Their Degradation Products
|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: NCT01828372|
Recruitment Status : Unknown
Verified April 2013 by Ali Mohammad Nejad Sigaroudi, University of Cologne.
Recruitment status was: Not yet recruiting
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
The study includes two study parts in which blood is collected from the patients.
Study part A (observational study, already received positive ethics committee vote; Our sign: 12-330): Use of blood samples gathered during routine blood withdrawal Study part B (interventional study in the sense of additional blood samples but without an investigational product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of 20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks.
The primary objective of this study is to gain an overview about drug concentrations in plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in patients. Any drug may be tested, however the initial focus is on antiinfective, antineoplastic, and antipsychotic drugs.
Many published studies show that there is a profound lack of information on pharmacokinetics and interactions of many commonly used drugs in clinical routine, and that drug concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic range (provided that such ranges are known at all).
|Condition or disease||Intervention/treatment||Phase|
|Liver Insufficiency Kidney Failure, Chronic Obesity Pregnancy Breast Feeding, Exclusive Sepsis Multiple Organ Failure||Other: additional blood withdrawals||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quantification of Drugs and Their Metabolites in Patients at the Cologne University Hospital|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||March 2017|
additional blood withdrawals
Theoretical anyone with taking a drug of interest (see "list of substances and metabolites of interest") can join this trial. But we turn mainly our attention to patient groups who are excluded in modern drug approval studies.
Other: additional blood withdrawals
Blood withdrawals by either venous puncture or placement of permanent venous catheter.
- Pharmacokinetic Outcome Measures (e.g., Cmax, AUC) [ Time Frame: within four weeks after administration of drug of interest ]These assessments rely on multiple measurements over time and the Time Frame may include multiple time points describing the interval at which data are collected
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): NCT01828372
|Contact: Uwe Fuhr, Professor||0049-221-478 ext email@example.com|
|Department of Pharmacology, Cologne University Hospital|
|Cologne, NRW, Germany, 50937|
|Contact: Uwe Fuhr, Professor firstname.lastname@example.org|
|Sub-Investigator: Ali Mohammad Nejad Sigaroudi, M.D.|
|Study Director:||Uwe Fuhr, Professor||Department of Pharmacology|