Please select the eligibility criteria that correspond to the clinical trial below.
Title: Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Brief Summary: The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Options:
A: Inclusion Criteria:

* Knee pain and osteophytes on radiographs OR
* Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes or less, and crepitus (cracking sound) during motion
* Experiences chronic pain for 6 months or longer
* Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
* If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl)
* Able to walk at least ½ a city block a day, and agrees to try and slowly increase that over the course of study
* Able to read and speak English and provide informed consent
* Able to understand and comply with all data collection methodology including electronic diary
* Subject agrees to 1) continue their stable drug regimen with no changes during the course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day) for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours before testing.

Exclusion Criteria:

* Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake blockers for mood disorders
* Subject is allergic to SSRIs, SNRIs, or milnacipran
* Subject has severe or untreated psychiatric disturbance (e.g. mania, depression, anxiety, substance dependence)
* Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or digoxin during the trial
* Subject has a clinical diagnosis of fibromyalgia
* Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g. polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention)
* Subject has cardiac implants
* Subject has a knee replacement
* Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery)
B: Inclusion Criteria:

* Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

* 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.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
C: Inclusion Criteria:

* Male or female outpatients with chronic low back pain

Exclusion Criteria:

* 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.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
D: Inclusion Criteria:

* Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

* 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.
* Previous exposure to duloxetine.

Answer: D