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

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02248480

14375

F1J-JE-HMGX (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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354 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

Placebo administered orally once a day for 15 weeks.

Treatment:

Drug: Placebo