Please select the eligibility criteria that correspond to the clinical trial below.
Title: Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
Brief Summary: To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.


Options:
A: 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).
B: Inclusion Criteria:

* Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
* May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
* Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion Criteria:

* Glycosylated hemoglobin (A1C) \> 12%
* Severe hepatic disease
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
* Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
* Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
* Treatment of fluoxetine within 30 days of starting the study.
* Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
C: Inclusion Criteria:

* HIV infected
* HIV-associated neuropathy
* Able and willing to provide informed consent
* Successful completion of a daily baseline pain diary over 1 week immediately prior to entry with a mean pain intensity of 4 or more on an 11-point Likert scale
* Karnofsky performance score of 60 or more within 45 days prior to entry
* Required laboratory values. More information on this criterion can be found in the study protocol.
* Willing to comply with protocol requirements for the duration of the study, to include daily completion of the pain diary as instructed, attendance at all study visits, and avoidance of prohibited medications
* On stable or no antiretroviral therapy for 30 days prior to entry. Participants on ARV therapy should plan to remain on the same regimen and drug dose for the duration of the study. Participants not on ARV therapy should have no plans to initiate therapy during study enrollment.
* Not pregnant

Exclusion Criteria:

* Conditions that confound a diagnosis of HIV-associated neuropathy or preclude accurate assessment of neuropathy symptoms, at the discretion of the site investigator. More information on this criterion can be found in the study protocol.
* Potential for unstable neuropathy symptoms during study participation due tthe following: (1) discontinuation of dideoxynucleoside nucleoside reverse transcriptase inhibitor (NRTI) within 16 weeks prior to entry, (2)treatment within 120 days prior to entry with any drug that the site investigator considers may contribute to sensory neuropathy
* Current history of significant depression on antidepressant therapy precluding withdrawal from antidepressants, upon impression of site investigator with input from the participant's mental health provider where available
* History of active substance abuse or dependence identified through medical chart review or self-report such that, in the opinion of the site investigator, participation poses undue risk for the participant
* History of alcohol-related complications within 6 months prior to entry that include but are not restricted to alcohol withdrawal seizures, alcoholic hallucinosis, delirium tremens, or being in an alcohol detoxification program - Treatment with tricyclic antidepressants, selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors (SNRIs), bupropion, or tramadol that, upon judgment of the site investigator, cannot be tapered and discontinued prior to the pre-entry visit
* Treatment with an analgesic opioid regimen of more than 60 mg oral morphine equivalent per day within 45 days prior to entry
* Cognitive impairment that, in the opinion of the site investigator and based on clinical impression, might impact the ability to comply with the study protocol
* Use of an investigational agent within 45 days prior to entry except for expanded-access drugs or drugs used in an ACTG protocol for HIV treatment or for HIV-associated complications, if the drug is not prohibited by this protocol
* Acute active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Participants with no evidence of active disease and receiving maintenance therapy of AIDS-related OIs will be eligible
* Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
* End-stage renal dialysis requiring hemodialysis
* History of known or suspected hepatic cirrhosis diagnosed by signs and symptoms, radiography, or prior liver biopsy with Metavir score of more than 2
* Prolonged QTc interval (more than 0.45 seconds) within 90 days prior to entry
* Felt to be at high risk of opioid-induced respiratory compromise. More information on this criterion can be found in the study protocol.
* Diagnosis of a new seizure disorder or seizure within 90 days prior to entry
* History of acute angle-closure glaucoma, at the discretion of the site investigator
* Known allergy/sensitivity or any hypersensitivity to duloxetine, methadone, acetaminophen, or their ingredients
* Breastfeeding
D: Inclusion Criteria:

* meet criteria from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination
* measure average pain item of the BPI at Visits 1 and 2

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)
* have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia

Answer: B