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)
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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