Overview

Duloxetine Versus Placebo in Chronic Low Back Pain

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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 patients with Chronic Low Back Pain.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Duloxetine Hydrochloride
Criteria
Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain.
Exclusion Criteria: - You have a serious or unstable disease 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, or 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 major depressive disorder. - Require daily
narcotics.