A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)

NCT00619476 | Completed Phase 2 Results

• 1 other identifier: 110748
• Study Type: interventional
• Target: 376
• Locations: 2 countries
• Sites: 83

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).

Conditions

Neuralgia, Postherpetic

Keywords

Neuropathic Pain; Post-herpetic neuralgia; PHN

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as EOMT score minus Baseline score.

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Secondary Outcomes (18)

• Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

• Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

• Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

• Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

• Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data

  Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

GEn 1200mg/day

EXPERIMENTAL

gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks

Drug: GEn 1200mg/day

GEn 2400mg/day

EXPERIMENTAL

gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks

Drug: GEn 2400mg/day

GEn 3600mg/day

EXPERIMENTAL

gabapentin enacarbil 3600mg/day, maintenance treatment 14 weeks

Drug: GEn 3600mg/day

Interventions

GEn 1200mg/day DRUG

gabapentin enacarbil 1200mg/day

Also known as: XP13512/GSK1838262, gabapentin enacarbil

GEn 1200mg/day

GEn 2400mg/day DRUG

gabapentin enacarbil 2400mg/day

Also known as: XP13512/GSK1838262, gabapentin enacarbil

GEn 2400mg/day

GEn 3600mg/day DRUG

gabapentin enacarbil 3600mg/day

Also known as: gabapentin enacarbil, XP13512/GSK1838262

GEn 3600mg/day

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (83)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Northport, Alabama, 35476, United States

Location

GSK Investigational Site

Chandler, Arizona, 85225, United States

Location

GSK Investigational Site

Gilbert, Arizona, 85234, United States

Location

GSK Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85251, United States

Location

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Arcadia, California, 91007, United States

Location

GSK Investigational Site

Huntington Park, California, 90255, United States

Location

GSK Investigational Site

New Port Beach, California, 92660, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

Oxnard, California, 93030, United States

Location

GSK Investigational Site

Redondo Beach, California, 90277, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

San Diego, California, 92117, United States

Location

GSK Investigational Site

San Francisco, California, 94109, United States

Location

GSK Investigational Site

Santa Monica, California, 90404, United States

Location

GSK Investigational Site

Boulder, Colorado, 80304, United States

Location

GSK Investigational Site

Bradenton, Florida, 34203, United States

Location

GSK Investigational Site

Bradenton, Florida, 34206, United States

Location

GSK Investigational Site

Daytona Beach, Florida, 32117, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Hollywood, Florida, 33021, United States

Location

GSK Investigational Site

Naranja, Florida, 33032, United States

Location

GSK Investigational Site

New Port Richey, Florida, 34652, United States

Location

GSK Investigational Site

Ocala, Florida, 34471, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33702, United States

Location

GSK Investigational Site

Tallahassee, Florida, 32308, United States

Location

GSK Investigational Site

Tampa, Florida, 33603, United States

Location

GSK Investigational Site

Tampa, Florida, 33607, United States

Location

GSK Investigational Site

Tampa, Florida, 33612, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Marietta, Georgia, 30066, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Libertyville, Illinois, 60048, United States

Location

GSK Investigational Site

Danville, Indiana, 46122, United States

Location

GSK Investigational Site

Elkhart, Indiana, 46514, United States

Location

GSK Investigational Site

Terre Haute, Indiana, 47802, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71101, United States

Location

GSK Investigational Site

Rockville, Maryland, 20852, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

GSK Investigational Site

Olive Branch, Mississippi, 38654, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63117, United States

Location

GSK Investigational Site

Reno, Nevada, 89502, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03766, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

GSK Investigational Site

Amherst, New York, 14226, United States

Location

GSK Investigational Site

Brooklyn, New York, 11235, United States

Location

GSK Investigational Site

New York, New York, 10004, United States

Location

GSK Investigational Site

New York, New York, 10128, United States

Location

GSK Investigational Site

Rochester, New York, 14642, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, United States

Location

GSK Investigational Site

Hickory, North Carolina, 28601, United States

Location

GSK Investigational Site

High Point, North Carolina, 27262, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45246, United States

Location

GSK Investigational Site

Norman, Oklahoma, 73071, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Eugene, Oregon, 97401, United States

Location

GSK Investigational Site

Medford, Oregon, 97501, United States

Location

GSK Investigational Site

Altoona, Pennsylvania, 16602, United States

Location

GSK Investigational Site

San Antonio, Texas, 78238, United States

Location

GSK Investigational Site

Weber City, Virginia, 24290, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Yakima, Washington, 98902, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 3G8, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 3J1, Canada

Location

GSK Investigational Site

London, Ontario, N5Y 5K7, Canada

Location

GSK Investigational Site

Niagara Falls, Ontario, L2E 6A6, Canada

Location

GSK Investigational Site

Thornhill, Ontario, L4J 6W6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2K 4L5, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

Location

GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: XenoPort Call Center
• Organization: XenoPort, Inc.

877-936-6778

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 22, 2013
• Results First Posted: May 20, 2011

Record last verified: 2013-01

Locations

CA (11); US (72)