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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00071708
Enrollment
Unknown
Registered
2003-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathic Pain, Fibromyalgia, Generalized Anxiety Disorder, Major Depressive Disorder

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.

Interventions

DRUGDuloxetine Hydrochloride

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026