NCT00692263

Brief 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. It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 10, 2008

Status Verified

September 1, 2008

Enrollment Period

6 months

First QC Date

June 3, 2008

Last Update Submit

September 9, 2008

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • AUC of (+)-M1 metabolite of tramadol

    24 hours

Secondary Outcomes (1)

  • Dynamic pupillometry

    24 hours

Study Arms (3)

A

EXPERIMENTAL

Escitalopram - tramadol

Drug: escitalopram and tramadol

B

EXPERIMENTAL

Placebo - tramadol

Drug: placebo and tramadol

C

EXPERIMENTAL

placebo - placebo

Drug: placebo

Interventions

escitalopram and tramadolDRUG

10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9

Also known as: Lexapro, Ultram
A
placeboDRUG

placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol

C
placebo and tramadolDRUG

9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9

Also known as: placebo, Ultram
B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Age: 18 - 45 years
  • CYP2D6 phenotyped as extensive metabolizer
  • CYP2C19 phenotyped as extensive metabolizer

You may not qualify if:

  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark

Odense, DK-5000, Denmark

Location

MeSH Terms

Interventions

EscitalopramTramadol

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Officials

  • Kim Brosen, MD, D.Sc

    Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 10, 2008

Record last verified: 2008-09

Locations

DK(1)