The Effect of Escitalopram on the Pharmacokinetics and Ph... | NCT00692263

Studies
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects

NCT00692263

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Sep 10, 2008Estimated

Enrollment

15Actual

Phase

Phase 4

Conditions

Healthy

Interventions

escitalopram and tramadol
placebo
placebo and tramadol

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2007-004470-10

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2008

Last Update Posted Date

Sep 10, 2008Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Escitalopram - tramadol	Drug: escitalopram and tramadol
B	Experimental	Placebo - tramadol	Drug: placebo and tramadol
C	Experimental	placebo - placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
escitalopram and tramadol	Drug	10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9	A

Measure	Description	Time Frame
AUC of (+)-M1 metabolite of tramadol		24 hours

Measure	Description	Time Frame
Dynamic pupillometry		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Alcohol or drug abuse

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Brosen, MD, D.Sc	Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark		Odense		DK-5000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D014147	Tramadol

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided