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

Phase 1

Active, not recruiting

• Conditions: Roux-en-Y gastric bypass; MedDRA version: 20.0Level: LLTClassification code 10033762Term: ParacetamolSystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2018-005006-62-NL
• Lead Sponsor: Albert Schweitzer hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-14
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified