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A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Duloxetine

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Have previously completed/withdrawn from this study or any other study investigating duloxetine (Note: Participants who have been previously screened for a duloxetine study other than this study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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine

Placebo

Arm Description

Double Blind Treatment Phase: 60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks. Extension Treatment Phase: 60 mg duloxetine administered by mouth QD for 13 weeks. Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).

Double Blind Treatment Phase: Placebo administered by mouth once a day (QD) for 13 weeks. Extension Treatment Phase: 60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD. Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).

Outcomes

Primary Outcome Measures

Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score

BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.

Secondary Outcome Measures

Patient Global Impressions of Improvement (PGI-I) Score

PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.

Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores

WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score

CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.

Change From Baseline in Brief Pain Inventory (BPI) Severity

BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.

Change From Baseline in Brief Pain Inventory (BPI) Interference

BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.

Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores

HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.

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)

Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.

Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score

Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses.

Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint

PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either "much better" or "very much better".The last observation carried forward (LOCF) method will be used for these analyses.

Full Information

NCT ID

NCT01931475

First Posted

August 26, 2013

Last Updated

April 14, 2016

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01931475

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

407 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score

Description

Time Frame

Baseline, Week 13

Secondary Outcome Measure Information:

Title

Patient Global Impressions of Improvement (PGI-I) Score

Description

Time Frame

13 Weeks

Title

Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score

Description

Time Frame

Baseline,13 Weeks

Title

Change From Baseline in Brief Pain Inventory (BPI) Severity

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline in Brief Pain Inventory (BPI) Interference

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores

Description

Time Frame

Baseline, Week 13

Title

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)

Description

Time Frame

Baseline, Week 13

Title

Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score

Description

Time Frame

Week 13

Title

Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint

Description

Time Frame

Week 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eil Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

City

Bengbu

ZIP/Postal Code

233004

Country

China

Facility Name

City

Changchun

ZIP/Postal Code

130033

Country

China

Facility Name

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510515

Country

China

Facility Name

City

Hefei

ZIP/Postal Code

230022

Country

China

Facility Name

City

Pingxiang

ZIP/Postal Code

337055

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

City

Shenyang

ZIP/Postal Code

110016

Country

China

Facility Name

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

City

Zhuzhou

ZIP/Postal Code

412007

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

36269595

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.

Results Reference

derived

PubMed Identifier

31505082

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.

Results Reference

derived

PubMed Identifier

31010413

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.

Results Reference

derived

PubMed Identifier

30962729

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.

Results Reference

derived

PubMed Identifier

28043937

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.

Results Reference

derived

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A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China

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