Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
Brief Summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Options:
A: Inclusion criteria:

* 18 years or older
* Female subjects are eligible to enter if of non-childbearing potential or not lactating, has a negative pregnancy test and agrees to use a specified highly effective method for avoiding pregnancy
* Documented medical diagnosis of Type 1 or 2 diabetes including:
* Stable glycemic control for 3 months defined as \<25% change of routine insulin, \<50% change of routine oral anti-diabetic agent dose and HbA1c \< 8%. (HbA1c of 8 to 11% eligible if attempts to improve diabetic control failed)
* DPN defined by:
* Bilateral reduced or absent reflexes at the ankles, or
* Bilateral impaired vibration, pinprick, fine touch or temperature perception in the distal lower extremities And
* Persistent distal burning or dull pain in the feet, or
* Persistent proximal aching pain in the legs, or
* Paroxysmal electric, shooting, stabbing pain, or
* Dysasthesias, or
* Evoked pain And
* history of pain for at least six months and no greater than five years attributed to DPN (refers to duration of pain)
* Baseline 24-hour average daily pain intensity score \>4.0 as measured on an 11 point pain intensity numerical rating scale
* Provides written informed consent in accordance with all applicable regulatory requirements

Exclusion criteria:

* Other chronic pain conditions not associated with DPN. However, the subject will not be excluded if:
* The pain condition is located at a different region of the body, and
* The pain intensity of this condition is not greater than the pain intensity of the DPN, and
* The subject can assess their DPN independently of other pain condition.
* Other causes of neuropathy or lower extremity pain
* Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
* Hepatic impairment defined as ALT or AST \> 2x upper limit of normal (ULN) or alkaline phosphatase or bilirubin \> 1.5x ULN
* Chronic hepatitis B or C
* Impaired renal function defined as either creatinine clearance \< 60 mL/min or requiring hemodialysis
* Corrected QT (QTc) interval \>450 msec or QTc interval \>480 msec for patients with Bundle Branch Block
* Uncontrolled hypertension at screen (sitting systolic \>160 mmHg and/or sitting diastolic \>90 mmHg
* Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s)
* Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn or pregabalin, or, in the investigator's judgment:
* Is considered to be clinically significant and could pose a safety concern or,
* Could interfere with the accurate assessment of safety or efficacy, or,
* Could potentially affect a subject's safety or study outcome
* Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active significant psychiatric disorders within last year
* Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication
* Antidepressant medication may not be changed or discontinued to met entry criteria and must be stable for at least 3 months prior to enrollment
* History of clinically significant drug or alcohol abuse (DSM-IV-TR). Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted
* Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device
* Has participated in a clinical study and was exposed to investigational or non-investigational drug or device:
* Within preceding month for studies unrelated to DPN, or
* Within six months for studies related to DPN
* Treated previously with GEn
* History of allergic or medically significant adverse reaction to investigational products (including gabapentin or pregabalin) or their excipients, acetaminophen or related compounds
B: Inclusion Criteria:

* Type 1 or 2 diabetes with painful neuropathy
* Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
* Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

* History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
* Participated in a previous or ongoing pregabalin clinical trial
* Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
C: Inclusion Criteria:

* Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
* Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

* Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
* A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
* Subject has clinically significant abnormalities in clinical laboratory tests.
D: Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
* At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
* At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
* Male or female of any race, at least 18 years of age, and using appropriate methods of contraception

Exclusion Criteria:

* Creatinine clearance \<30 mL/min (estimated from serum creatinine).
* Skin conditions in the affected dermatome that could alter sensation
* Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin

Answer: C