Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice
Brief Summary: Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice


Options:
A: Inclusion Criteria:

* Men or women 18 years or older with diagnosis of type 1 or type 2 diabetes who have reported symmetrical painful symptoms in distal extremities for 1-5 years prior to the study and whose symptoms are attributable to sensorimotor diabetic peripheral neuropathy (DPN).
* Patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control.
* Patient has pain score of at least 4 on the 11-point Likert numerical rating scale at screening. Potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization.
* Patient has a mean baseline week pain intensity of at least 4 on the 11-point Likert scale at the end of a one-week pre-treatment period and has completed at least 4 days of diary entries during the baseline week.
* Patient is on stable regimen of antidiabetes medication at screening that can be maintained during the study.
* Patient has hemoglobin A1c (HbA1c) ≤11% at screening.
* Patient has FPG ≤310 mg/dL at screening.
* Patient must have a minimum washout of greater than 5 times the half-life of the drug of any of several medications
* Patients currently treated with gabapentin or pregabalin at screening may be eligible for the study, but must have tapering period wherein the dose of gabapentin is reduced gradually over a period of at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the Baseline Week.
* Patient must have adequate eyesight to complete questions on the DiaryPro and SitePro. If a patient is unable to do so (for reasons other than severe eye disease) but a caregiver is available to complete these tasks following instruction from the patient, the caregiver may be trained to accomplish these tasks

Exclusion Criteria:

* Patients who have previously not responded to treatment for DPN with gabapentin at doses of ≥1200 mg/day or pregabalin at doses ≥300 mg/day.
* Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
* Patient has hypersensitivity to gabapentin.
* Patient is a nursing mother.
* Patient has used injected anesthetics or steroids within 30 days of baseline.
* Patient has certain conditions that could confound evaluation of painful DPN, in particular, amputations other than toes, non-diabetic neurologic disorders (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.
* Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
* Patient is in an immunocompromised state.
* Patient has an estimated creatinine clearance of \<60 ml/min calculated using the Cockroft Gault method (Appendix 3).
* Patient has had malignancy within past 2 years other than basal cell carcinoma.
* Patient has had gastric reduction surgery.
* Patient has severe chronic diarrhea, chronic constipation \[unless attributed to drugs that will be washed out\], uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
* Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
* Patient has a history of substance abuse within the past year.
* Patient has had 1 or more visits to an emergency room or hospital within the previous 30 days due to hypoglycemia.
* Patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma.
* Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
* Patient has any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
* Continuing use of any concomitant medication excluded by Inclusion Criterion 8.
* Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit
B: DISEASE CHARACTERISTICS:

* Has received or is currently receiving neurotoxic chemotherapy, including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin), or vinca alkaloids (e.g., vincristine or vinblastine)
* Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy

  * Average daily pain rating of at least 4 out of 10 using the pain numerical rating scale (where 0 is no pain and 10 is the worst pain possible) OR
  * Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common

    * Toxicity Criteria for sensory neuropathy
* No other identified causes of painful paresthesia existing prior to chemotherapy

  * No radiotherapy-induced or malignant plexopathy
  * No lumbar or cervical radiculopathy
  * No pre-existing peripheral neuropathy of another etiology, including:

    * B12 deficiency
    * AIDS
    * Monoclonal gammopathy
    * Diabetes
    * Heavy metal poisoning
    * Amyloidosis
    * Syphilis
    * Hyperthyroidism or hypothyroidism
    * Inherited neuropathy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Life expectancy:

* At least 6 months

Renal:

* Creatinine no greater than 1.5 times upper limit of normal

Other:

* No prior allergic reaction or intolerance to gabapentin
* No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study compliance
* No extreme difficulty swallowing pills
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Other:

* More than 30 days since prior investigational agent for pain control
* Concurrent selective serotonin reuptake inhibitors allowed
* Concurrent nonsteroidal anti-inflammatory drugs allowed
* No concurrent tricyclic antidepressant (e.g., amitriptyline, nortriptyline, or desipramine)\*
* No concurrent monoamine oxidase inhibitor\*
* No concurrent opioid analgesic\*
* No other concurrent adjuvant analgesic (e.g., anticonvulsant, clonazepam, or mexiletine)\*
* No concurrent topical analgesics (e.g., lidocaine gel or lidocaine patch)\*
* No concurrent amifostine
* No concurrent investigational agent for pain control NOTE: \* For pain or symptoms due to chemotherapy-induced peripheral neuropathy
C: Inclusion Criteria:

* Men or Women 18 years or older who are suffering from PHN

Exclusion Criteria:

* Patient is Pregnant or a nursing mother
* Patient has hypersensitivity to gabapentin
* Patient has an estimated creatinine clearance of \<30 mL/min or is in hemodialysis
D: Inclusion Criteria:

* 18 years or older
* Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
* 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.
* Currently on a stable dose of 1800 mg/day of gabapentin for ≥2 weeks with inadequate response OR
* Not currently treated with gabapentin, but previously treated with ≥1800 mg/day of gabapentin for 4 weeks or more with inadequate response.
* 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
* Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* 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

Answer: C