CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug (MEMO)

This study is currently recruiting participants.
Verified January 2012 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01519726
First received: January 4, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 4, 2012
January 24, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery [ Time Frame: 0.5-2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01519726 on ClinicalTrials.gov Archive Site
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CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug

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 substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.

Not Provided
Interventional
Phase 4
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Morbid Obesity
Drug: Midazolam
Experimental: Morbidly obese patients
Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI>40
  • undergoing bariatric surgery

Exclusion Criteria:

  • use of drug inducing or inhibiting CYP3A4 activity
  • pregnancy, breastfeeding
  • renl insufficiency
Both
18 Years to 60 Years
No
Not Provided
Netherlands
 
NCT01519726
MEMO study
Not Provided
Catherijne Knibbe, St. Antonius Hospital
St. Antonius Hospital
Not Provided
Not Provided
St. Antonius Hospital
January 2012

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