An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)

Inclusion Criteria

(Consecutive Participants)

• Participants who have completed the 15-week treatment in the preceding study HMGX.

(New Participants)

• Participants with present osteoarthritis (OA) based on American College of Rheumatology (ACR) classification of idiopathic OA of the knee.
• Have pain for ≥14 days of each month for 3 months prior to study entry.
• Have a score of ≥4 on the BPI average pain score at the start of the study.

(Consecutive and New Participants)

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

Exclusion Criteria

(New Participants)

• 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 received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 week.
• Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at any time.
• 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 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 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 enrollment.
• Have had previous exposure to duloxetine or completed/withdrawn from any study investigating duloxetine.

(Consecutive and New Participants)

• 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 having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or 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 uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
• Participants who have end stage bone disease or surgery planned during the trial for the index joint.
• Participants treated with a monoamine oxidase inhibitor (MAO) 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).
• Have a primary painful condition that may interfere with assessment of the index joint, i.e., knee.
• 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.
• Participants who cannot use appropriate contraceptive method or do not want to use that from the start