The amount of paracetamol in blood before and after a gastric bypass procedure

Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass - PAPAYA

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-005006-62-NL

Enrollment

Registered

2019-10-14

Start date

2019-12-10

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Roux-en-Y gastric bypass MedDRA version: 20.0 Level: LLT Classification code 10033762 Term: Paracetamol System Organ Class: 100000004848

Interventions

Trade Name: Paracetamol Product Name: Paracetamol Pharmaceutical Form: Tablet INN or Proposed INN: paracetamol CAS Number: 103-90-2 Current Sponsor code: paracetamol Other descriptive name: PARACETAMO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - at least 18 years old - on the waiting list of getting a Roux-en-Y gastric bypass - mentally competent - provided informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - to undergo gastric band, gastric sleeve, mini gastric bypass or revision RYGB - to undergo procedures for gastric band, RYGB or gastric sleeve previously - taken paracetamol < 24 h before blood sampling at t=0 - allergy or intolerance for paracetamol - not being able to take paracetamol orally - to vomit after intake of paracetamol - to be pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery. ;Secondary Objective: To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of the metabolites paracetamol glucuronide (PCM-GLU), paracetamol sulfate (PCM-SUL), paracetamol mercatopurate (PCM-MER) and paracetamol cysteine (PCM-CYS) after a single oral dose of 1000 mg paracetamol before the surgery, within one month after the surgery and 6 months after the surgery. To assess the effect of a single dose of 1000 mg paracetamol on aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (?-GT) and bilirubin after 6 and 24 hours of oral intake of paracetamol before and after Roux-en-Y gastric bypass;Primary end point(s): The primary end point is the pharmacokinetics of paracetamol after a single oral dose of 1000 mg before and after RYGB. ;Timepoint(s) of evaluation of this end point: The end point is determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB.	—

Measure

Time frame

Main Objective: To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery. ;Secondary Objective: To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of the metabolites paracetamol glucuronide (PCM-GLU), paracetamol sulfate (PCM-SUL), paracetamol mercatopurate (PCM-MER) and paracetamol cysteine (PCM-CYS) after a single oral dose of 1000 mg paracetamol before the surgery, within one month after the surgery and 6 months after the surgery. To assess the effect of a single dose of 1000 mg paracetamol on aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (?-GT) and bilirubin after 6 and 24 hours of oral intake of paracetamol before and after Roux-en-Y gastric bypass;Primary end point(s): The primary end point is the pharmacokinetics of paracetamol after a single oral dose of 1000 mg before and after RYGB. ;Timepoint(s) of evaluation of this end point: The end point is determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end point is the pharmacokinetics of the metabolites (paracetamol glucuronide, paracetmol sulfate, paracetamol mercatopurate and paracetamol cysteine) after a single oral dose of 1000 mg paracetamol before and after RYGB Additional secondary end points are ASAT, ALAT, ?-GT and bilirubin values. ;Timepoint(s) of evaluation of this end point: The pharmacokinetic profiles are determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB. The liver values are determined at T=0, T=6 h and T=24 h at each of the timepoints at which a plasma-concentration curve is measured.	—

Measure

Time frame

Secondary end point(s): Secondary end point is the pharmacokinetics of the metabolites (paracetamol glucuronide, paracetmol sulfate, paracetamol mercatopurate and paracetamol cysteine) after a single oral dose of 1000 mg paracetamol before and after RYGB Additional secondary end points are ASAT, ALAT, ?-GT and bilirubin values. ;Timepoint(s) of evaluation of this end point: The pharmacokinetic profiles are determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB. The liver values are determined at T=0, T=6 h and T=24 h at each of the timepoints at which a plasma-concentration curve is measured.

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Countries

Netherlands

Contacts

Public ContactHospital Pharmacy

Albert Schweitzer hospital

s.f.lau@asz.nl+31786523213

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026