A Study for Patient With Chronic Low Back Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Chronic Low Back Pain

Treatments: Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767806

F1J-MC-HMGC (Other Identifier)

12360

Details and patient eligibility

About

The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients with chronic low back pain

Exclusion criteria

• Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
• Acute liver injury (such as hepatitis) or severe cirrhosis.
• Previous exposure to duloxetine.
• Body Mass Index (BMI) over 40.
• Major depressive disorder.
• Daily use of narcotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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401 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

Patients received placebo by mouth once daily for 12 weeks of double-blind treatment

Treatment:

Drug: Placebo