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

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuropathy, Diabetic

In brief

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)

Key facts

Study ID

NCT00643760

Run by

XenoPort, Inc.

People needed

421

Starts

2008-03-01

Expected to finish

2009-02-01

Last updated by the study team

2013-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Hoover, Alabama, United States
• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Muscle Shoals, Alabama, United States
• GSK Investigational Site — Northport, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Peoria, Arizona, United States
• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Concord, California, United States
• GSK Investigational Site — Escondido, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Park, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Los Gatos, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Oxnard, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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