Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

NCT03161509 | Terminated Phase 4

• 1 other identifier: 0563-16-RMB
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC

  sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC

  8 hours

Study Arms (2)

paracetamol

EXPERIMENTAL

10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy

Drug: Paracetamol

antiepileptic drug

EXPERIMENTAL

Up to 10 participants in each drug (up to 4 medications, total of up to 40 participants) will undergo measurement of levels of their chronic medication after a dose before and after sleeve gastrectomy

Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)

Interventions

Paracetamol DRUG

single dose of 1 gr paracetamol

paracetamol

Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) DRUG

Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

Also known as: Antiepileptic

antiepileptic drug

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI over 30 and eligible for sleeve gastrectomy
• Mentally capable for consent
• (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

You may not qualify if:

• Gastrointestinal illness impairing absorption
• renal failure (glomerular filtration rate\<45)
• liver cirrhosis
• heart failure (New York Heart Association class III or IV)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Healthcare Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Acetaminophen; Anticonvulsants; Lamotrigine; Phenytoin; Valproic Acid

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Azoles; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Irit Hochberg, MD/PhD

  Rambam Healthcare Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Attending physician in Institute of Endocrinology, Diabetes and Metabolism

Model Details: All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 19, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: September 24, 2021

Record last verified: 2017-05

Locations

IL (1)