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Duloxetine - Warfarin Pharmacodynamic Study

NCT ID: NCT00533026

Last Updated: 2008-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-10-31

Brief Summary

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To evaluate the blood clotting effects of multiple doses of warfarin at steady state when taken at the same time as multiple doses of duloxetine as measured by changes in the International Normalised Ratio. All subjects will begin dosing with warfarin, then after approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either continue dosing at 60 mg or have a dose increase to 120 mg.

Detailed Description

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Conditions

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Anticoagulant Effect of Warfarin When Taken With Duloxetine.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Subjects received warfarin QD, PO for approximately 12 days. Subjects with stabilized INR after approximately 12 days continued to receive warfarin QD, PO for an additional 14 days and also received duloxetine 60mg QD, PO for the 14 days. Duloxetine doses were tapered, subjects received 30mg QD, PO for 4 days. No warfarin was received during the taper phase.

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Warfarin

Intervention Type DRUG

B

Subjects received warfarin QD, PO for approximately 12 days. Subjects with stabilized INR after approximately 12 days continued to receive warfarin QD, PO for an additional 14 days and also received duloxetine 60 mg QD, PO for 4 days followed by duloxetine 120 mg QD, PO for 10 days. Duloxetine doses were tapered, subjects received 60mg QD, PO for 4 days followed by 30mg QD, PO for 4 days. No warfarin was received during the taper phase.

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Interventions

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Duloxetine

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Other Intervention Names

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LY248686 Cymbalta

Eligibility Criteria

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Inclusion Criteria

Healthy men or women between ages 18 and 64 years.

Exclusion Criteria

Have a personal history, family history of, or current evidence of: a bleeding disorder, have Positive Faecal Occult Blood (FOB) sample at screening, significant neuropsychiatric disease (including a history of suicide attempts or who have exhibited suicidal ideation or who are at significant risk to commit suicide, as judged by the investigator), significant active respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.

Use or intended use of aspirin or NSAIDs within 2 weeks prior to first dosing.

Subjects who have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females). Subjects who smoke more than 5 cigarettes per day.

Use or intended us of a drug that inhibits or induces CYP1A2 or inhibits CYP2D6 within 2 weeks prior to first dosing occasion or during the study.

Have received any drug that acts as a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to first dosing occasion or have a potential need to use an MAOI during the conduct of this study or within 2 weeks after discontinuation of study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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F1J-MC-HMFP

Identifier Type: -

Identifier Source: secondary_id

11707

Identifier Type: -

Identifier Source: org_study_id