CClinicalTrials.gg
Approved for marketingNCT00071708Updated Jan 10, 2025

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

An expanded access record providing Duloxetine Hydrochloride in Major Depressive Disorder, Fibromyalgia and Diabetic Peripheral Neuropathic Pain, sponsored by Eli Lilly and Company. Approved for marketing at 13 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Eli Lilly and Company · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
  • Fibromyalgia
  • Diabetic Peripheral Neuropathic Pain
  • Generalized Anxiety Disorder
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

Browse Fibromyalgia studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Access details

Study type
Expanded access

Available treatment

  • DrugDuloxetine Hydrochloride
06

Where to request access

13 sites
  • 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 2021, Australia
  • 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.
    Everton Park, Queensland 4053, Australia
  • 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.
    Maroochydore, Queensland 4558, Australia
  • 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.
    Southport, Queensland 4215, Australia
  • 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.
    Spring Hill, Queensland 4000, Australia
  • 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.
    Elizabeth Vale, South Australia 5112, Australia
  • 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.
    Keswick, South Australia 5035, Australia
  • 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.
    Box Hill, Victoria 3128, Australia
  • 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.
    Hoppers Crossing, Victoria 3030, Australia
  • 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.
    Melbourne, Victoria 3168, Australia
  • 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.
    Richmond, Victoria 3121, Australia
  • 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.
    Nedlands, Western Australia 6009, Australia
  • 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 6005, Australia
07

References and documents

Publications

  • Pangallo BA, Zhang Q, Desaiah D, Perahia DG, Detke MJ, Kennedy SH. Long-term safety of duloxetine during open-label compassionate use treatment of patients who completed previous duloxetine clinical trials. Curr Med Res Opin. 2010 Nov;26(11):2643-51. doi: 10.1185/03007995.2010.522157. Epub 2010 Oct 11. PubMed 20932222 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00071708
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 30, 2003
Last update
Jan 10, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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