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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00071708
First received: October 29, 2003
Last updated: July 30, 2008
Last verified: July 2008
  Purpose

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 Intervention
Major Depressive Disorder
Fibromyalgia
Diabetic Peripheral Neuropathic Pain
Generalized Anxiety Disorder
Drug: Duloxetine Hydrochloride

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Eli Lilly and Company

Additional 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
Study First Received: October 29, 2003
Last Updated: July 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Depressive Disorder, Major
Diabetic Neuropathies
Disease
Fibromyalgia
Myofascial Pain Syndromes
Neuralgia
Behavioral Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Mood Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Pathologic Processes
Peripheral Nervous System Diseases
Rheumatic Diseases
Signs and Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2014