Bariatric Surgery CandidatePhase 4NCT03161509
Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy
A Phase 4 study testing Paracetamol and Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) in people with Bariatric Surgery Candidate, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Paracetamol and Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2017to 1 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI over 30 and eligible for sleeve gastrectomy
- Mentally capable for consent
- (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug
Who cannot join
- Gastrointestinal illness impairing absorption
- renal failure (glomerular filtration rate<45)
- liver cirrhosis
- heart failure (New York Heart Association class III or IV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Paracetamol, Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
single dose of 1 gr paracetamol
Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)Drug
Also called Antiepileptic
Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose
| Study group | Role | What they receive |
|---|---|---|
| paracetamol | Experimental | 10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy Receives: 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 Receives: Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC
sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jul 2017
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Why it stopped: publication of better study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irit HOCHBERG MD, Rambam Health Care Campus
- Investigators
- Irit Hochberg, MD/PhD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161509
- Sponsor's protocol ID
- 0563-16-RMB
- Status last verified
- May 2017
- First submitted
- 27 Apr 2017
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
- ClinicalTrials.gov ID
- NCT03161509
- Acronym / sponsor ID
- 0563-16-RMB
- Conditions
- Bariatric Surgery Candidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: publication of better study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Experimental | Drug: Paracetamol10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy |
| antiepileptic drug | Experimental | 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI over 30 and eligible for sleeve gastrectomy
- Mentally capable for consent
- (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug
Key exclusion criteria (4 listed)
- Gastrointestinal illness impairing absorption
- renal failure (glomerular filtration rate<45)
- liver cirrhosis
- heart failure (New York Heart Association class III or IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamolsingle dose of 1 gr paracetamol | Drug | paracetamol |
| Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)Also: AntiepilepticSingle dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose | Drug | antiepileptic drug |
Primary outcome
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
Results and safety
The study was stopped early (reason given: publication of better study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Hochberg, MD/PhD principal investigator
Rambam Healthcare Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) in people with Bariatric Surgery Candidate, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: publication of better study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.