Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
Brief Summary: The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Options:
A: Inclusion Criteria:

* You must have been diagnosed with Diabetic Neuropathic Pain
* Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
* Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
* Patient must agree not to change dose of gabapentin between Visits 1 and 2
* You must have stable glycemic control

Exclusion Criteria:

* Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
* Current diagnosis or history of hemangiosarcoma
* Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
* Patients with uncontrolled narrow-angle glaucoma
* Presence of a current seizure disorder
B: Inclusion Criteria:

* If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
* If female, subject must have negative results for pregnancy tests.
* The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
* Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
* Subject has an HgbA1c \<= 9. Subjects who have an HgbA1c \> 9 and \<= 11 may be included in the study.
* If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Exclusion Criteria:

* The subject has failed previous treatment with duloxetine for DNP.
* Subject has a diagnosis of narrow-angle glaucoma.
* Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
* Subject has a diagnosis of fibromyalgia that requires treatment.
* Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
* Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
* Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
* Subject has unstable angina.
* Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
* Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
* Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) \>= 160 and/or a diastolic blood pressure (BP) \>= 100 at Screening and/or Baseline.
* Subject has a clinically significant abnormal ECG at Screening
* Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
* Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
* Subject's screening laboratory results show hepatitis A, B or C.
* Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).
C: Inclusion Criteria:

* Male/Female outpatients 18 years of age with chronic low back pain
* Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

* Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
* Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
* Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
* Have acute liver injury (such as hepatitis) or severe cirrhosis
* Have had previous exposure to duloxetine
* Have a body mass index (BMI) over 40
* Have a major depressive disorder
* Require daily narcotics
* Have suicidal risk
* Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
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