Status:
COMPLETED
Duloxetine Versus Placebo in Chronic Low Back Pain
Lead Sponsor:
Eli Lilly and Company
Conditions:
Back Pain Without Radiation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily can help ...
Eligibility Criteria
Inclusion
- Male/Female outpatients 18 years of age with chronic low back pain
- Females of child bearing potential must test negative on a pregnancy test at visit 1.
Exclusion
- Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
- Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
- Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
- Have acute liver injury (such as hepatitis) or severe cirrhosis
- Have had previous exposure to duloxetine
- Have a body mass index (BMI) over 40
- Have a major depressive disorder
- Require daily narcotics
- Have suicidal risk
- Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00424593
Start Date
January 1 2007
End Date
October 1 2008
Last Update
November 20 2009
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
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 p
Curitiba, Brazil, 80060240
2
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 p
São Paulo, Brazil, 04026-000
3
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 p
São Paulo, Brazil, 04027-000
4
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 p
Amiens, France, 80054