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

• Conditions: Major Depressive Disorder; Fibromyalgia; Diabetic Peripheral Neuropathic Pain; Generalized Anxiety Disorder

• Registration Number: NCT00071708
• Lead Sponsor: Eli Lilly and Company

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 effective alternative therapy is not available.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-10-29
• Study First Submitted QC: 2003-10-29
• Study First Posted: 2003-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

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.; 🇦🇺 West Perth, Western Australia, Australia