HealthyPhase 4NCT00692263
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
A Phase 4 study testing escitalopram and tramadol in people with Healthy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- escitalopram and tramadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Aug 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age: 18 - 45 years
- CYP2D6 phenotyped as extensive metabolizer
- CYP2C19 phenotyped as extensive metabolizer
Who cannot join
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, DK-5000
About this study
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol
- Conditions
- Healthy
- Being tested
- escitalopram and tramadol, placebo, placebo and tramadol
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram and tramadolDrug
Also called Lexapro, Ultram
10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9
placeboDrug
placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
placebo and tramadolDrug
Also called placebo, Ultram
9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Escitalopram - tramadol Receives: Drug: escitalopram and tramadol |
| B | Experimental | Placebo - tramadol Receives: Drug: placebo and tramadol |
| C | Experimental | placebo - placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of (+)-M1 metabolite of tramadol
Measured: 24 hours
Secondary outcomes (1)
Dynamic pupillometry
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Kim Brosen, MD, D.Sc, Study chair, Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692263
- Sponsor's protocol ID
- AKF-372
- Other IDs
- EudraCT: 2007-004470-10
- Status last verified
- Sep 2008
- First submitted
- 3 Jun 2008
- Last updated
- 10 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00692263
- Acronym / sponsor ID
- AKF-372
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Jun 2008 (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.
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: escitalopram and tramadolEscitalopram - tramadol |
| B | Experimental | Drug: placebo and tramadolPlacebo - tramadol |
| C | Experimental | Drug: placeboplacebo - placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Age: 18 - 45 years
- CYP2D6 phenotyped as extensive metabolizer
- CYP2C19 phenotyped as extensive metabolizer
Key exclusion criteria (1 listed)
- Alcohol or drug abuse
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 |
|---|---|---|
| escitalopram and tramadolAlso: Lexapro, Ultram10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9 | Drug | A |
| placeboplacebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol | Drug | C |
| placebo and tramadolAlso: placebo, Ultram9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9 | Drug | B |
Primary outcome
AUC of (+)-M1 metabolite of tramadol
Time frame: 24 hours
1 secondary outcome
Dynamic pupillometry
Time frame: 24 hours
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 10 Sep 2008.
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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.
Kim Brosen, MD, D.Sc study chair
Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
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 escitalopram and tramadol in people with Healthy, run by University of Southern Denmark 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 4 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 10 Sep 2008. 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?
AUC of (+)-M1 metabolite of tramadol (time frame: 24 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 10 Sep 2008.