A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Intervention: Duloxetine; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 458.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Chronic Low Back Pain; CLBP

Summary:

      The purpose of the study is to assess the efficacy and safety of duloxetine in participants
      with Chronic Low Back Pain (CLBP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with CLBP present for the preceding 6 months or longer

          -  Participants used nonsteroidal anti-inflammatory drugs for CLBP for more than 14 days
             on average per month in the past 3 months and more than 14 days in one month prior to
             screening

          -  Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score
             before randomized

          -  Female participants having child-bearing potential must test negative (-) on a
             pregnancy test

        Exclusion Criteria:

          -  Participants have received treatment within the last 30 days with a drug that has not
             received regulatory approval for any indication

          -  Participants having a history of low back surgery

          -  Participants having received epidural steroids, facet block, nerve block or other
             invasive procedures aimed to reduce low back pain within one month prior to screening

          -  Participants who have any difficulties to fulfill diary appropriately

          -  Participants having any previous diagnosis of psychosis, bipolar disorder, or
             schizoaffective disorder

          -  Participants having major depressive disorder as determined using depression module of
             the Mini-International Neuropsychiatric Interview

          -  Participants having primary painful condition due to other than CLBP

          -  Participants being anticipated by the investigator to require use of nonsteroidal
             anti-inflammatory drugs and includes acetaminophen, opioid analgesics, or other
             excluded medication for the duration of the study

          -  Participants being considered as inappropriate for participation to the study for any
             medical or other reason as judged by the investigator

          -  Participants answering "yes" to any of the questions about active suicidal
             ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity
             Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)

          -  Participants having a positive urine drug screen for any substances of abuse or
             excluded medication

          -  Participants having alanine aminotransferase or aspartate aminotransferase higher than
             100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram
             per deciliter (mg/dL)

          -  Participants having serum creatinine level higher than 2.0 mg/dL, or had renal
             transplantation or receiving renal dialysis

          -  Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
             history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension

          -  Participants have had previous exposure to duloxetine or completed / withdrawn from
             any study investigating duloxetine

          -  Participants having serious or unstable cardiovascular, hepatic, renal, metabolic,
             respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other
             medical condition or psychiatric conditions that, in the opinion of investigator,
             would compromise participation or be likely to lead to hospitalization during the
             course of the study

          -  Participants have known hypersensitivity to multiple medications

          -  Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis

          -  Participants taking any excluded medications that cannot be discontinued

          -  Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the
             potential need to use an MAOI during the study or within 5 days of discontinuation of
             study drug

          -  Participants are non-ambulatory or require the use of crutches or a walker

          -  Participants having a history of substance abuse or dependence within the past year,
             excluding nicotine and caffeine

          -  Pregnant participants or participants were breast-feeding, or wished to be pregnant
             during the clinical trial period

          -  Participants cannot use appropriate contraceptive method or do not want to use that
             from screening until one month after the end of administration of the investigational
             drug