Status:
COMPLETED
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
Lead Sponsor:
St. Antonius Hospital
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and subs...
Eligibility Criteria
Inclusion
- BMI\>40
- undergoing bariatric surgery
Exclusion
- use of drug inducing or inhibiting CYP3A4 activity
- pregnancy, breastfeeding
- renl insufficiency
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01519726
Start Date
December 1 2011
End Date
December 1 2013
Last Update
April 4 2019
Active Locations (1)
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1
St Antonius Hospital
Nieuwegein, Netherlands