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Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

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ClinicalTrials.gov Identifier: NCT01764555
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date April 5, 2019
Study Start Date  ICMJE December 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]
  • Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01764555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • 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 ]
  • 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 ]
  • Liver function tests in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Acetaminophen in Morbidly Obese Patients
Official Title  ICMJE Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Drug: acetaminophen 2 g
Study Arms  ICMJE
  • Experimental: normal weight patients
    normal weight patients receiving acetaminophen 2 g instead of 1 g
    Intervention: Drug: acetaminophen 2 g
  • Experimental: mobidly obese patients
    morbidly obese patients receiving acetaminophen 2 g instead of 1 g
    Intervention: Drug: acetaminophen 2 g
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2013)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01764555
Other Study ID Numbers  ICMJE APAP study
2012-000956-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catherijne Knibbe, St. Antonius Hospital
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherijne Knibbe, Prof dr St. Antonius Hospital
PRS Account St. Antonius Hospital
Verification Date April 2019

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