Overview

A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Shionogi
Treatments:
Duloxetine Hydrochloride
Criteria
Inclusion Criteria:

- Participants with present OA.

- Have pain for ≥ 14 days of each month for 3 months prior to study entry.

- Participants must have a score of ≥4 on the BPI average pain score before
randomization.

- Females of child-bearing potential must test negative (-) on a pregnancy test.

Exclusion Criteria:

- Participants who cannot appropriately complete the daily diaries.

- Have a score change of ≧3 on BPI 24-hour average pain score between screening and
baseline.

- Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory,
or hematologic illness, peripheral vascular disease, or other medical condition or
neuropsychiatric conditions or clinically significant laboratory abnormalities or
electrocardiographic abnormalities.

- Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) higher than 100 international units per liter (IU/L) or total bilirubin higher
than 1.6 milligrams/deciliter (mg/dL).

- Participants who have serum creatinine level higher than 2.0 mg/dL, or had renal
transplantation or are receiving renal dialysis.

- Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid
arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and
Type 1 diabetes).

- Participants who have any previous diagnosis of psychosis, bipolar disorder, or
schizoaffective disorder.

- Participants who have major depressive disorder as determined using depression module
of the Mini-International Neuropsychiatric Interview (M.I.N.I.).

- Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.

- Participants who have received intrarticular hyaluronate or steroids, joint lavage, or
other invasive therapies to the knee in the past 1 month.

- Participants who have had knee arthroscopy of the index knee within the past year or
joint replacement of the index knee or osteotomy at anytime.

- Participants who have end-stage osteoarthritis or surgery planned during the trial for
the index joint.

- Participants have a prior synovial fluid analysis showing a white blood cell (WBC)
≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.

- Participants taking any excluded medications that cannot be discontinued.

- Participants anticipated by the investigator to require use of nonsteroidal
anti-inflammatory drugs that include acetaminophen, opioid analgesics, or other
excluded medication for the duration of the study.

- Participants treated with a monoamine oxidase inhibitor (MAoI) within 14 days prior to
baseline, or those with the potential need to use MAO inhibitor during the study or
within 5 days of discontinuation of investigational drug.

- Participants who answer '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 behaviors section).

- Participants who have a history of having more than one medical allergy.

- Are non-ambulatory or require the use of crutches or a walker.

- Have frequent falls that could result in hospitalization or could compromise response
to treatment.

- Have a primary painful condition that may interfere with assessment of the index
joint, i.e., knee.

- Have a history of drug abuse or dependence within the past year, including alcohol and
excluding nicotine and caffeine.

- Have a positive urine drug screen for any substances of abuse or excluded medication.

- Have received administration of another investigational drug within the 30 days prior
to screening.

- Have had previous exposure to duloxetine or completed/withdrawn from any study
investigating duloxetine.

- Pregnant participants, female participants who wish to be pregnant during the clinical
study period, or participants who are breast-feeding; or male participants who wish
pregnancy of the partner.