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

Lilly

Status

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

Treatments: Drug: Duloxetine Hydrochloride

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00071708

F1J-MC-HMCN

7443

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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