Conditions

Back Pain Without Radiation

Outcome Measures

Primary Outcomes (1)

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline, Week 13

Secondary Outcomes (18)

Patient's Global Impression of Improvement (PGI-I)
Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Baseline, Week 13, Week 54
+13 more secondary outcomes

Other Outcomes (2)

Serious Adverse Events During the Dose-Blind Extension Phase
Week 13 though Week 54
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Week 13 through Week 54

Study Arms (2)

Duloxetine

EXPERIMENTAL

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

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DuloxetineDRUG

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

Also known as: LY248686, Cymbalta

Duloxetine

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.