Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Phase 4

Terminated

• Conditions: Bariatric Surgery Candidate
• Interventions: Drug: Paracetamol; Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)

• Registration Number: NCT03161509
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-04-27
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-07-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paracetamol	Paracetamol	10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy
antiepileptic drug	Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC	8 hours	sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC

Trial Locations

Locations (1)

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel