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Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

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ClinicalTrials.gov Identifier: NCT01764555
Recruitment Status : Unknown
Verified January 2013 by Catherijne Knibbe, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: acetaminophen 2 g Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients
Study Start Date : December 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: normal weight patients
normal weight patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g
Experimental: mobidly obese patients
morbidly obese patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g


Outcome Measures

Primary Outcome Measures :
  1. Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]
  2. Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 8 hours ]
  2. 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. [ Time Frame: 8 hours ]
  3. Liver function tests in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for morbidly obese patients:

  • BMI > 40 kg/m2 undergoing bariatric surgery.
  • Patients between 18 - 60 years old
  • ASA physical classification of II or III
  • All racial and ethnic groups will be included

Inclusion criteria for control group:

  • BMI between 18 and 25 kg/m2 undergoing general surgery
  • Patients between 18 - 60 years old
  • ASA (American Society of Anesthesiology) physical classification of I, II or III
  • All racial and ethnic groups will be included

Exclusion criteria for all study arms:

  • Renal insufficiency
  • Liver disease
  • Patients with Gilbert-Meulengracht syndrome
  • Chronic alcohol intake or use of alcohol within last 72 hours
  • Pregnancy or breastfeeding
  • Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
  • Diabetes mellitus type II patients
  • Smoking
  • Acetaminophen intake before the study (24 hours before study)
Contacts and Locations

Information from the National Library of Medicine

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): NCT01764555


Contacts
Contact: Anne van Rongen, MSc 030-6093500 a.van.rongen@antoniusziekenhuis.nl

Locations
Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Anne van Rongen, MSc    030-6093500    a.van.rongen@antoniusziekenhuis.nl   
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Catherijne Knibbe, Prof dr St. Antonius Hospital
More Information

Responsible Party: Catherijne Knibbe, Prof. dr., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01764555     History of Changes
Other Study ID Numbers: APAP study
2012-000956-32 ( EudraCT Number )
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics