Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan
Brief 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.


Options:
A: Inclusion Criteria:

* primary knee osteoarthritis

Exclusion Criteria:

* inflammatory conditions
* autoimmune disorders
* psychiatric illness
* morbid obesity
B: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
C: 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.
D: Inclusion Criteria:

* male or female patients
* aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
* have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
* all females must test negative for pregnancy at the time of enrollment
* have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria:

* have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
* have regional pain syndrome, multiple surgeries or failed back syndrome
* have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)

Answer: C