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NCT03161509 Clinical Trial

Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

Official title:
Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03161509
Other study ID # 0563-16-RMB
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 1, 2017
Est. completion date January 1, 2019

Study information
Verified date May 2017
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date January 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Paracetamol
single dose of 1 gr paracetamol
• 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

Locations
Country Name City State
Israel Rambam Healthcare Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC 8 hours
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