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Status:

COMPLETED

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

Lead Sponsor:

XenoPort, Inc.

Conditions:

Neuropathy, Diabetic

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 diabetic per...

Detailed Description

This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2009

    Estimated Enrollment :

    421 Patients enrolled

    Trial Details

    Trial ID

    NCT00643760

    Start Date

    March 1 2008

    End Date

    February 1 2009

    Last Update

    July 22 2013

    Active Locations (90)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 23 (90 locations)

    1

    GSK Investigational Site

    Alabaster, Alabama, United States, 35007

    2

    GSK Investigational Site

    Birmingham, Alabama, United States, 35205

    3

    GSK Investigational Site

    Dothan, Alabama, United States, 36303

    4

    GSK Investigational Site

    Hoover, Alabama, United States, 35216