Duloxetine Versus Placebo in Chronic Low Back Pain

• Status: Completed
• Trial end date: 2008-10-01
• 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.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

• 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

• Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

• 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