HealthyPhase 4NCT02303106
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
A Phase 4 study testing Lamotrigine in people with Healthy, run by Per Damkier at 1 site in Denmark.
Trial summary
The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers. Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Apr 2015
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy no medication use
- Informed consent
Who cannot join
- Allergy to paracetamol or lamotrigine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.
Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.
Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.
- Conditions
- Healthy
- Being tested
- Lamotrigine
- Keywords
- AUC exposure to lamotrigine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
| Study group | Role | What they receive |
|---|---|---|
| lamotrigine | Active comparator | lamotrigine alone Receives: Drug: Lamotrigine |
| Lamotrigine + paracetamol | Experimental | Lamotrigine + paracetamol Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lamotrigine AUC
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Damkier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Damkier, Odense University Hospital
- Investigators
- Per Damkier, MD, Principal investigator, Head Consultant Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303106
- Sponsor's protocol ID
- AKF-386
- Status last verified
- Apr 2015
- First submitted
- 21 Nov 2014
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
- ClinicalTrials.gov ID
- NCT02303106
- Acronym / sponsor ID
- AKF-386
- Conditions
- Healthy
- Keywords
- AUC exposure to lamotrigine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Per DamkierUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.
Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.
Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lamotrigine | Active comparator | Drug: Lamotriginelamotrigine alone |
| Lamotrigine + paracetamol | Experimental | Drug: LamotrigineLamotrigine + paracetamol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy no medication use
- Informed consent
Key exclusion criteria (1 listed)
- Allergy to paracetamol or lamotrigine
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 |
|---|---|---|
| Lamotrigine | Drug | Lamotrigine + paracetamol, lamotrigine |
Primary outcome
Lamotrigine AUC
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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.
Per Damkier, MD principal investigator
Head Consultant Clinical Pharmacology
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 Lamotrigine in people with Healthy, run by Per Damkier at 1 site in Denmark.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2015. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lamotrigine AUC (time frame: 24 hour). 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 22 Apr 2015.