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Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Terminated
CT.gov ID
NCT03161509
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Paracetamol
  • Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)
 Phase 4

Detailed Description

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects.

Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomyAll participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: paracetamol

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

Drug: Paracetamol
single dose of 1 gr paracetamol
Experimental: antiepileptic drug

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC [8 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. BMI over 30 and eligible for sleeve gastrectomy

    2. Mentally capable for consent

    3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

    Exclusion Criteria:

    1. Gastrointestinal illness impairing absorption

    2. renal failure (glomerular filtration rate<45)

    3. liver cirrhosis

    4. heart failure (New York Heart Association class III or IV)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Healthcare Campus Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    • Principal Investigator: Irit Hochberg, MD/PhD, Rambam Healthcare Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Irit HOCHBERG MD, Principle investigator, Attending physician in Institute of Endocrinology, Diabetes and Metabolism, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT03161509
    Other Study ID Numbers:
    • 0563-16-RMB
    First Posted:
    May 19, 2017
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acetaminophen
    Lamotrigine
    Carbamazepine
    Phenytoin
    Valproic Acid
    Anticonvulsants

    Study Results

    No Results Posted as of Sep 24, 2021