Duloxetine Versus Placebo in Chronic Low Back Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Back Pain Without Radiation

Treatments: Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408876

10545 (Registry Identifier)

F1J-MC-HMEO

Details and patient eligibility

About

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.

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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404 participants in 4 patient groups, including a placebo group

Duloxetine 20 mg

Experimental group

Description:

duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks

Treatment:

Drug: Duloxetine

Duloxetine 60 mg

Experimental group

Description:

duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks

Treatment:

Drug: Duloxetine

Duloxetine 120 mg

Experimental group

Description:

duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

placebo once a day (QD), by mouth (PO) for 13 weeks

Treatment:

Drug: Placebo