Clinical trial NCT01931475: A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China
Official title: Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 407
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.


Eligibility criteria: Inclusion Criteria:

* Meet clinical and radiographic criteria for the diagnosis of OA of the knee or hip with pain for ≥14 days of each month for 3 months prior to study entry
* Have a rating ≥4 on the Brief Pain Inventory (BPI) 24-hour average pain item (Question 3 of the BPI modified short form) at both Screening and Randomization

Exclusion Criteria:

* Have previously completed/withdrawn from this study or any other study investigating duloxetine (Note: Participants who have been previously screened for a duloxetine study other than this study and never received investigational product will be eligible for this study if they meet all current entry criteria)
* Have had previous exposure to duloxetine
* Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
* Current (within 1 year of Screening) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I diagnosis of major depressive disorder, anxiety disorders (excluding phobias), alcohol or eating disorders, as determined by the Mini-International Neuropsychiatric Interview or a previous diagnosis
* Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
* Are taking any excluded medications that cannot be discontinued at Screening
* Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
* Have a positive urine drug screen for any substance of abuse or excluded medication
* Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
* Have a history of recurrent seizures other than febrile seizures
* Are judged clinically by the investigator to be at suicidal risk according to the Columbia - Suicide Severity Rating Scale (C-SSRS): a "Yes" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the"Suicidal Ideation" portion of the C-SSRS or a "Yes" answer to any of the suicide related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C-SSRS, with the ideation/behavior having occurred within the previous month
* Have uncontrolled narrow-angle glaucoma
* Have acute liver injury (such as hepatitis) or severe cirrhosis
* Have known hypersensitivity to duloxetine or any of the inactive ingredients or have frequent/severe allergic reactions to multiple medications
* Have frequent falls that could result in hospitalization or could compromise response to treatment
* Have a diagnosis of inflammatory arthritis \[that is, rheumatoid arthritis (RA)\] or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis)
* Have received intra-articular hyaluronate/steroids, joint lavage, or other invasive therapies to the index joint in the previous 3 months
* Have had arthroscopy of the index joint within the previous year or joint replacement of the index joint at any time
* Have surgery of the index joint scheduled to occur during the trial or are anticipated by the investigator to require surgery for the treatment of the OA of the index hip or knee along the duration of the study
* Have had a prior synovial fluid analysis showing a white blood cell (WBC) count ≥2000 cubic millimeter (mm3) that is indicative of a diagnosis other than OA
* Are non-ambulatory or require the use of crutches or a walker
* Have a body mass index \>40
* Are anticipated by the investigator to require use of analgesic agents including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study

Primary outcomes:
measure: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score
timeFrame: Baseline, Week 13
Secondary outcomes:
measure: Patient Global Impressions of Improvement (PGI-I) Score
timeFrame: 13 Weeks
measure: Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
timeFrame: Baseline, Week 13
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score
timeFrame: Baseline,13 Weeks
measure: Change From Baseline in Brief Pain Inventory (BPI) Severity
timeFrame: Baseline, Week 13
measure: Change From Baseline in Brief Pain Inventory (BPI) Interference
timeFrame: Baseline, Week 13
measure: Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores
timeFrame: Baseline, Week 13
measure: Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)
timeFrame: Baseline, Week 13
measure: Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score
timeFrame: Week 13
measure: Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
timeFrame: Week 13
Other outcomes:
Locations:
city: Beijing
country: China
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.
city: Bengbu
country: China
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.
city: Changchun
country: China
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.
city: Changsha
country: China
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.
city: Chengdu
country: China
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.
city: Guang Zhou
country: China
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.
city: Hefei
country: China
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.
city: Pingxiang
country: China
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.
city: Shanghai
country: China
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.
city: Shenyang
country: China
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.
city: Tianjin
country: China
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.
city: Zhuzhou
country: China
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: Eil Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5PM Eastern Time (UTC/GMT-5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2.
citation: Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.
citation: Wang G, Bi L, Li X, Li Z, Zhao D, Chen J, He D, Wang CN, Wu T, Duenas H, Skljarevski V, Yue L. Maintenance of effect of duloxetine in Chinese patients with pain due to osteoarthritis: 13-week open-label extension data. BMC Musculoskelet Disord. 2019 Apr 22;20(1):174. doi: 10.1186/s12891-019-2527-y.
citation: Yue L, Luo S, Wang Y, Wang CN, Duenas HJ, Skljarevski V. Clinical meaningfulness of duloxetine's effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase 3 randomized trial. Open Access Rheumatol. 2019 Mar 21;11:67-76. doi: 10.2147/OARRR.S193044. eCollection 2019.
citation: Wang G, Bi L, Li X, Li Z, Zhao D, Chen J, He D, Wang CN, Duenas H, Skljarevski V, Yue L. Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2017 Jun;25(6):832-838. doi: 10.1016/j.joca.2016.12.025. Epub 2016 Dec 31.