Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Status:

APPROVED_FOR_MARKETING

Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Lead Sponsor:

Eli Lilly and Company

Conditions:

Major Depressive Disorder

Fibromyalgia

Eligibility:

All Genders

18+ years

Brief Summary

The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom eff...

Eligibility Criteria

Inclusion

Male and Female outpatients at least 18 years of age who have previously participated in a Lilly sponsored neuroscience duloxetine clinical trial
All females must have a negative urine pregnancy test at visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control.
Must sign the informed consent document

Exclusion

Have received treatment within the last 30 days with a drug except for duloxetine that has not received regulatory approval for any indication at the time of study entry
In the opinion of the investigator, patient judged to be at serious suicidal risk.
Serious or unstable hepatic or renal function or unstable narrow angle glaucoma.
Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to visit 1 or potential to use a MAOI during the study or within 5 days of discontinuation of study drug.
Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00071708

Last Update

January 10 2025

Active Locations (13)

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Page 1 of 4 (13 locations)

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

Paddington, New South Wales, Australia, 2021

Everton Park, Queensland, Australia, 4053