Clinical trial NCT00643760 (phase 2, status: completed)
Conditions: neuropathy, diabetic
ICD codes: E10.40, E11.40, E13.40, E10.43, E11.43, E13.43, E08.40
Drugs: placebo, gen 1200mg/day, gen 2400mg/day, gen 3600mg/day, pregabalin
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1, CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1, CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1, NCC1(CC(O)=O)CCCCC1
Eligibility criteria:

        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