A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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 diabetic peripheral neuropathy(DPN)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XenoPort, Inc.
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Pregabalin

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