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A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

CompletedPhase 3NCT01855919
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Low Back Pain in Japan
Sponsor
Eli Lilly and Company
Collaborators
Shionogi
Start date
2013-05
Primary completion
2014-07
Sex
All
Age range
from 20 Years to 79 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Japan
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 com…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01855919