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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00071708
Recruitment Status : No longer available
First Posted : October 30, 2003
Last Update Posted : August 1, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Major Depressive Disorder Fibromyalgia Diabetic Peripheral Neuropathic Pain Generalized Anxiety Disorder Drug: Duloxetine Hydrochloride

Study Design

Study Type : Expanded Access
Official Title: Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Interventions

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071708


Locations
Australia, New South Wales
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
Australia, Queensland
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, Australia, 4053
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, Australia, 4558
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, Australia, 4215
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, Australia, 4000
Australia, South 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, Australia, 5112
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, Australia, 5035
Australia, Victoria
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, Australia, 3128
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, Australia, 3030
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, Australia, 3168
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, Australia, 3121
Australia, Western 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, Australia, 6009
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, 6005
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00071708     History of Changes
Other Study ID Numbers: 7443
F1J-MC-HMCN
First Posted: October 30, 2003    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Anxiety Disorders
Fibromyalgia
Neuralgia
Diabetic Neuropathies
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents