Status:
COMPLETED
A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
Lead Sponsor:
XenoPort, Inc.
Conditions:
Neuralgia, Postherpetic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The primary purpose of study PXN110527 was to investigate the efficacy of a high (3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic neuralgia (PHN) who have a histo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00617461
Start Date
March 1 2008
End Date
July 1 2009
Last Update
July 22 2013
Active Locations (53)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85016
2
GSK Investigational Site
Oxnard, California, United States, 93030
3
GSK Investigational Site
Roseville, California, United States, 95661
4
GSK Investigational Site
San Francisco, California, United States, 94109