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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

407

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2013

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

August 26, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed

3 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

12 months until next milestone

Results Posted

Study results publicly available

May 23, 2016

Completed

Last Updated

May 23, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

August 26, 2013

Results QC Date

February 29, 2016

Last Update Submit

April 14, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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.
Baseline, Week 13

Secondary Outcomes (9)

Patient Global Impressions of Improvement (PGI-I) Score
13 Weeks
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
Baseline, Week 13
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score
Baseline,13 Weeks
Change From Baseline in Brief Pain Inventory (BPI) Severity
Baseline, Week 13
Change From Baseline in Brief Pain Inventory (BPI) Interference
Baseline, Week 13
+4 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL

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).

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

DuloxetineDRUG

Administered orally

Also known as: LY248686, Cymbalta

Duloxetine

PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (12)

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.

Beijing, 100029, China

Location

Bengbu, 233004, China

Location

Changchun, 130033, China

Location

Changsha, 410013, China

Location

Chengdu, 610041, China

Location

Guangzhou, 510515, China

Location

Hefei, 230022, China

Location

Pingxiang, 337055, China

Location

Shanghai, 200433, China

Location

Shenyang, 110016, China

Location

Tianjin, 300052, China

Location

Zhuzhou, 412007, China

Location

Related Publications (5)

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.
PMID: 36269595DERIVED
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.
PMID: 31505082DERIVED
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.
PMID: 31010413DERIVED
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.
PMID: 30962729DERIVED
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.
PMID: 28043937DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eil Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

May 23, 2016

Results First Posted

May 23, 2016

Record last verified: 2016-04

Locations

CN(12)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Duloxetine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations