Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Drug: acetaminophen 2 g

• Registration Number: NCT01764555
• Lead Sponsor: St. Antonius Hospital

Brief Summary

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mobidly obese patients	acetaminophen 2 g	morbidly obese patients receiving acetaminophen 2 g instead of 1 g
normal weight patients	acetaminophen 2 g	normal weight patients receiving acetaminophen 2 g instead of 1 g

Primary Outcome Measures

Name	Time	Method
Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.	24 hours
Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.	24 hours

Secondary Outcome Measures

Name	Time	Method
Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.	8 hours
Difference in volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.	8 hours
Liver function tests in morbidly obese patients in comparison with normal weight patients.	24 hours

Trial Locations

Locations (1)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands