Recruitment

Recruitment Status
Completed
Estimated Enrollment
450

Inclusion Criterias

Female participants having child-bearing potential must test negative (-) on a pregnancy test
Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score before randomized
Participants with CLBP present for the preceding 6 months or longer
...
Female participants having child-bearing potential must test negative (-) on a pregnancy test
Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score before randomized
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

Exclusion Criterias

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 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 having primary painful condition due to other than CLBP
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 received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Participants are non-ambulatory or require the use of crutches or a walker
Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview
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 history of substance abuse or dependence within the past year, excluding nicotine and caffeine
Participants have known hypersensitivity to multiple medications
Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine
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 a history of low back surgery
Participants having a positive urine drug screen for any substances of abuse or excluded medication
Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
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 having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
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
Participants taking any excluded medications that cannot be discontinued
Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
Pregnant participants or participants were breast-feeding, or wished to be pregnant during the clinical trial period
Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
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 who have any difficulties to fulfill diary appropriately

Summary

Conditions
Back Pain Lower Back Chronic
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 79 years
Gender
Both males and females

Inclusion Criterias

Female participants having child-bearing potential must test negative (-) on a pregnancy test
Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score before randomized
Participants with CLBP present for the preceding 6 months or longer
...
Female participants having child-bearing potential must test negative (-) on a pregnancy test
Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score before randomized
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

Exclusion Criterias

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 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 having primary painful condition due to other than CLBP
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 received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Participants are non-ambulatory or require the use of crutches or a walker
Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview
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 history of substance abuse or dependence within the past year, excluding nicotine and caffeine
Participants have known hypersensitivity to multiple medications
Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine
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 a history of low back surgery
Participants having a positive urine drug screen for any substances of abuse or excluded medication
Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
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 having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
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
Participants taking any excluded medications that cannot be discontinued
Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
Pregnant participants or participants were breast-feeding, or wished to be pregnant during the clinical trial period
Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
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 who have any difficulties to fulfill diary appropriately

Locations

Saitama
Saitama

Tracking Information

NCT #
NCT01855919
Collaborators
Shionogi
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company