Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN)
Brief Summary: The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN).


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:

* 18 years or older
* Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy
* Documented medical diagnosis of PHN of with pain present for at least three months from the healing of a herpes zoster rash
* Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
* Provides written informed consent in accordance with all applicable regulatory requirements

Exclusion Criteria:

* Other chronic pain conditions not associated with PHN. However, the subject will not be excluded if:
* The pain is located at a different region of the body; and
* The pain intensity is not greater than the pain intensity of the PHN; and
* The subject can assess PHN pain independently of other 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 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 drugs
* Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
* Is considered to be clinically significant and may 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 meet entry criteria and must be stable for at least three months prior to enrollment
* History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to refrain from substance abuse throughout the study. 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 PHN, or
* Within preceding six months for studies related to PHN
* Treated previously with GEn
* History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds
C: Inclusion Criteria:

1. Male between 18 and 55 years of age inclusive, at the time of signing the informed consent.
2. Body weight ≥ 50 Kilogram (kg) and BMI within the range 18.5-29.9 Killogram per square meter (kg/m2) (inclusive).
3. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
4. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper Limit of Normal (ULN)
5. QT duration corrected for heart rate by Bazett's formula (QTcB) or QT duration corrected for heart rate by Fridericia's formula (QTcF) \< 450 milli second (msec).

Exclusion Criteria:

1. The subject has either a previous disease or current medical condition, which as judged by the Investigator, may compromise safety or affect the interpretation of efficacy data.
2. History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
3. Abnormalities in 12-lead Electrocardiogram (ECG)
4. Systolic blood pressure (BP) below 90 or above 160mm Hg, or diastolic blood pressure below 50 or above 100 millimeters of mercury (mmHg).
5. History of sensitivity to any of the study medications
6. History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 millil litre \[ml\]) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
7. A positive pre-study drug/alcohol screen at the screening visit.
8. Excessive caffeine drinkers (\~5 or more cups a day) .
9. Excessive smokers (\>5 /day)
10. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to screening, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
11. Use of any topical steroid or capsaicin preparations in the previous 30 days to screening, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
12. The subject is needle phobic
13. The subject is unable to tolerate the electrical hyperalgesia model or nerve stimulation, including anxiety or atypical response to the stimulation on the training at the screening visit.
14. The subject does not produce an area of allodynia or hyperalgesia to the electrical hyperalgesia model during the screening session.
15. Subject who, in the investigator/designee's judgement, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any evidence of suicidal ideation on any questionnaires e.g. type 4 or 5 on the C-SSRS in the last 6 months.
16. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the baseline session in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
17. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 84 day period.
18. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
19. Unwillingness or inability to follow the procedures outlined in the protocol.
D: Inclusion Criteria:

* Confirmed diagnosis of acute HZ
* Pain intensity \> 30 mm visual analog scale

Exclusion Criteria:

* Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
* Patients under age
* Uncompliance
* Pregnancy or lactation
* Surgery within the last 3 month
* Severe heart/lung/kidney disease
* Diseases influencing the quality of life
* Psychiatric diseases (e.g., depression, schizophrenia, dementia)
* Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
* Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
* Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)

Answer: B