Clinical trial NCT01855919: A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Official title: Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Low Back Pain in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain Lower Back Chronic
Keywords: Chronic Low Back Pain
CLBP
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2013-05-17
Enrollment: 458
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item
timeFrame: Baseline, Week 14
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I) at Week 14
timeFrame: Week 14
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14
timeFrame: Baseline, Week 14
measure: Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14
timeFrame: Baseline, Week 14
measure: Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score
timeFrame: Baseline through Week 14
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14
timeFrame: Baseline, Week 14
measure: Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]
timeFrame: Baseline through Week 14
measure: Percentage of Participants With Fall Events in Fall Questionnaire
timeFrame: Baseline through Week 14
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Enomoto H, Sasaki N, Fujikoshi S, Yoshikawa A, Tsuji T, Takeshita K. Relationship Between Pain Alleviation and Disease-specific Health-related Quality of Life Measures in Patients With Chronic Low Back Pain Receiving Duloxetine: Exploratory Post Hoc Analysis of a Japanese Phase 3 Randomized Study. J Am Acad Orthop Surg Glob Res Rev. 2019 Nov 27;3(11):e18.00086. doi: 10.5435/JAAOSGlobal-D-18-00086. eCollection 2019 Nov.
citation: Tsuji T, Itoh N, Ishida M, Ochiai T, Konno S. Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study. J Pain Res. 2017 Sep 4;10:2157-2168. doi: 10.2147/JPR.S138172. eCollection 2017.