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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00071708
Registration number
NCT00071708
Ethics application status
Date submitted
29/10/2003
Date registered
30/10/2003
Date last updated
23/10/2023
Titles & IDs
Public title
Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial
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Scientific title
Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial
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Secondary ID [1]
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F1J-MC-HMCN
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Secondary ID [2]
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7443
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Fibromyalgia
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Diabetic Peripheral Neuropathic Pain
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Generalized Anxiety Disorder
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Mental Health
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Depression
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Mental Health
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Anxiety
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Intervention/exposure
Study type
Expanded Access
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Description of intervention(s) / exposure
Treatment: Drugs - Duloxetine Hydrochloride
Treatment: Drugs: Duloxetine Hydrochloride
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
No longer available
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment hospital [5]
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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
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Recruitment hospital [6]
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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
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Recruitment hospital [7]
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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
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Recruitment hospital [8]
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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
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Recruitment hospital [9]
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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
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Recruitment hospital [10]
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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
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Recruitment hospital [11]
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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
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Recruitment hospital [12]
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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
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Recruitment hospital [13]
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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
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Recruitment postcode(s) [1]
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2021 - Paddington
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Recruitment postcode(s) [2]
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4053 - Everton Park
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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4000 - Spring Hill
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [7]
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5035 - Keswick
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3030 - Hoppers Crossing
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Recruitment postcode(s) [10]
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3168 - Melbourne
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Recruitment postcode(s) [11]
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3121 - Richmond
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Recruitment postcode(s) [12]
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6009 - Nedlands
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Recruitment postcode(s) [13]
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6005 - West Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00071708
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00071708
Download to PDF