A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment

Completed · Phase 2

Conditions studied: Neuralgia, Postherpetic

In brief

The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.

Key facts

Study ID

NCT00617461

Run by

XenoPort, Inc.

People needed

96

Starts

2008-03-01

Expected to finish

2009-07-01

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
• Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
• Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy.
• Currently on a stable dose of 1800 mg/day of gabapentin for ≥2 weeks with inadequate response OR
• Not currently treated with gabapentin, but previously treated with ≥1800 mg/day of gabapentin for 4 weeks or more with inadequate response.
• Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
• Provides written informed consent in accordance with all applicable regulatory requirements

You may not qualify if…

• Other chronic pain conditions not associated with PHN. However, the subject will not be excluded if:
• The pain is located at a different region of the body; and
• The pain intensity is not greater than the pain intensity of the PHN; and
• The subject can assess PHN pain independently of other 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 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 drugs
• Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
• Is considered to be clinically significant and may 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
• Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• 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 meet entry criteria and must be stable for at least three months prior to enrollment
• History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to refrain from substance abuse throughout the study. 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 PHN, or
• Within preceding six months for studies related to PHN
• Treated previously with GEn

Where it is running

• GSK Investigational Site — Oxnard, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Bradenton, Florida, United States
• GSK Investigational Site — Chipley, Florida, United States
• GSK Investigational Site — Daytona Beach, Florida, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Marianna, Florida, United States
• GSK Investigational Site — Miami Springs, Florida, United States
• GSK Investigational Site — Naranja, Florida, United States
• GSK Investigational Site — South Miami, Florida, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Terre Haute, Indiana, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Missoula, Montana, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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