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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.
Study NCT00071708   Information provided by Eli Lilly and Company
First Received: October 29, 2003   Last Updated: July 30, 2008   History of Changes

October 29, 2003
July 30, 2008
 
 
 
 
Complete list of historical versions of study NCT00071708 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

 
 
Expanded Access
 
  • Major Depressive Disorder
  • Fibromyalgia
  • Diabetic Peripheral Neuropathic Pain
  • Generalized Anxiety Disorder
Drug: Duloxetine Hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
No longer available
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00071708
Chief Medical Officer, Eli Lilly
7443, F1J-MC-HMCN
Eli Lilly and Company
 
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
Eli Lilly and Company
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP