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Trial record 67 of 89 for:    CARBAMAZEPINE AND Psychotropic

Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT03161509
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Irit HOCHBERG MD, Rambam Health Care Campus

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
Bariatric Surgery Candidate 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 gastrectomy
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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 Name: Antiepileptic




Primary Outcome Measures :
  1. Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC [ Time Frame: 8 hours ]
    sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161509


Contacts
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Contact: Irit Hochberg, MD/PhD +972-4-7772150 i_hochberg@rambam.health.gov.il
Contact: Sigalit Cohen +972-4-7771606 si_cohen@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Irit Hochberg, MD/PhD Rambam Healthcare Campus

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Responsible Party: Irit HOCHBERG MD, Principle investigator, Attending physician in Institute of Endocrinology, Diabetes and Metabolism, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03161509     History of Changes
Other Study ID Numbers: 0563-16-RMB
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carbamazepine
Psychotropic Drugs
Acetaminophen
Lamotrigine
Phenytoin
Valproic Acid
Anticonvulsants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Voltage-Gated Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inducers