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Recruiting NCT03538457

Bariatric Surgery and Pharmacokinetics of Paracetamol

— Observational Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paracetamol.
Who it may be relevant to
Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bariatric Surgery and Pharmacokinetics of Paracetamol: BAR-MEDS Paracetamol

Overview

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on paracetamol are investigated.

Interventions

  • Drug Paracetamol
    Patients are tested for their normal prescription paracetamol medication

Primary outcome measures

  • Paracetamol concentration in blood serum (area under curve (AUC)) [Time frame: From baseline to 1 year postoperatively]

Eligibility criteria

Inclusion criteria

  • Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
  • Being a Norwegian citizen

Exclusion criteria

  • Having previously undergone resections in the GI-tract

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • St. Olavs University Hospital — Trondheim

Identifiers

NCT: NCT03538457 · 2016/1145v

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗