NCT01519726

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

January 4, 2012

Last Update Submit

April 3, 2019

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery

    0.5-2 years

Study Arms (1)

Morbidly obese patients

EXPERIMENTAL
Drug: Midazolam

Interventions

MidazolamDRUG
Morbidly obese patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>40
  • undergoing bariatric surgery

You may not qualify if:

  • use of drug inducing or inhibiting CYP3A4 activity
  • pregnancy, breastfeeding
  • renl insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Netherlands

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Midazolam

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Pharmacology, Hospital pharmacist

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 27, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

NL(1)