Clinical trial NCT00619476: A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)
Official title: Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Keywords: Neuropathic Pain
Post-herpetic neuralgia
PHN
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 post-herpetic neuralgia (PHN).

Detailed description: The primary purpose of study PXN110748 was to evaluate efficacy and safety of 3 fixed doses of GEn in the treatment of PHN.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 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
* Documented medical diagnosis of PHN of with pain present for at least three months from the healing of a herpes zoster rash
* 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 Criteria:

* 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
* 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

Primary outcomes:
measure: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Secondary outcomes:
measure: Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data
timeFrame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score
timeFrame: Anytime post-baseline until date of last dose of study medication (up to Week 13)
measure: Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (Week 13 or early withdrawal)
measure: Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data
timeFrame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
measure: Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data
timeFrame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Other outcomes:
Locations:
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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state: California
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city: San Diego
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city: San Francisco
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city: Santa Monica
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city: Boulder
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state: Colorado
city: Bradenton
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state: Florida
city: Bradenton
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facility: GSK Investigational Site
state: Florida
city: Daytona Beach
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facility: GSK Investigational Site
state: Florida
city: Hallandale Beach
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state: Florida
city: Hollywood
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state: Florida
city: Naranja
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state: Florida
city: New Port Richey
country: United States
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state: Florida
city: Ocala
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state: Florida
city: St. Petersburg
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city: Tampa
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facility: GSK Investigational Site
state: Florida
city: Tampa
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state: Florida
city: Decatur
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state: Georgia
city: Marietta
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city: Chicago
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city: Elkhart
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city: Boston
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city: Bingham Farms
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state: Michigan
city: Olive Branch
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city: St. Louis
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facility: GSK Investigational Site
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city: Reno
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facility: GSK Investigational Site
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city: Lebanon
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city: Albuquerque
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facility: GSK Investigational Site
state: New Mexico
city: Amherst
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facility: GSK Investigational Site
state: New York
city: Brooklyn
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facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: High Point
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Norman
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Eugene
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facility: GSK Investigational Site
state: Oregon
city: Medford
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facility: GSK Investigational Site
state: Oregon
city: Altoona
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Weber City
country: United States
facility: GSK Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Yakima
country: United States
facility: GSK Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivières
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: