Duloxetine Versus Placebo in Chronic Low Back Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Back Pain Without Radiation

Treatments: Drug: Placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424593

10544 (Registry Identifier)

F1J-MC-HMEN

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.

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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

every day (QD), by mouth (PO), 13 weeks

Treatment:

Drug: Placebo