Drug-Disease Interaction in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01261286|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 16, 2010
Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.
Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a surrogate marker of sympathetic nervous activity, will be similar between the healthy patients and the CD patients; the sympathetic nervous system of the heart will be similar to healthy patients; Crohn's disease patients with normal CRP will have higher drug response compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have higher verapamil response than those with similar symptom profiles who are not infliximab treated.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: verapamil||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients|
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): NCT01261286
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G-2B7|
|Principal Investigator:||Richard Fedorak, MD||University of Alberta|