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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Duloxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eil Lilly and Company

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.

Clinical Details

Official title: Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from Baseline to 13 Weeks in the Brief Pain Inventory (BPI) 24-hour Average Pain Rating

Secondary outcome:

Patient Global Impressions of Improvement (PGI-I) at 13 Weeks

Change from Baseline to 13 Weeks in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores

Change from Baseline to 13 Weeks in Clinical Global Impression of Severity (CGI-S)

Change from Baseline to 13 Weeks in BPI Severity

Change from Baseline to 13 Weeks in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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- Have previously completed/withdrawn from this study or any other study investigating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

- 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

Locations and Contacts

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

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., Bengbu 233004, China

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., Changchun 130033, China

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., Changsha 410013, China

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., Chengdu 610041, China

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., Guang Zhou 510515, China

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., Hefei 230022, China

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., Pingxiang 337055, China

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., Shanghai 200433, China

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., Shenyang 110016, China

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., Tianjin 300052, China

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., Zhuzhou 412007, China

Additional Information

Starting date: December 2012
Last updated: June 26, 2015

Page last updated: August 20, 2015

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