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

NCT00617461 | Completed Phase 2 Results

• 1 other identifier: 110527
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 53

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.

Conditions

Neuralgia, Postherpetic

Keywords

Post-herpetic neuralgia(PHN); Neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data

  Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants rated their API 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 end of treatment minus baseline. Data are summarized by dose, independent of treatment period.

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

• Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period

  Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Secondary Outcomes (16)

• Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

• Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

• Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

• Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

• Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

  Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Study Arms (2)

GEn 1200mg/day

EXPERIMENTAL

gabapentin enacarbil 1200mg/day, 4 weeks treatment in either the first or second treatment period

Drug: GEn 1200mg/day

GEn 3600mg/day

EXPERIMENTAL

gabapentin enacarbil 3600mg/day, 4 weeks treatment in either the first or second treatment period

Drug: GEn 3600mg/day

Interventions

GEn 1200mg/day DRUG

1200mg/day gabapentin enacarbil

Also known as: GEn, XP13512/GSK1838262, gabapentin enacarbil

GEn 1200mg/day

GEn 3600mg/day DRUG

3600mg/day gabapentin enacarbil

Also known as: gabapentin enacarbil, GEn, XP13512/GSK1838262

GEn 3600mg/day

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
• 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

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (53)

GSK Investigational Site

Phoenix, Arizona, 85016, United States

Location

GSK Investigational Site

Oxnard, California, 93030, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

San Francisco, California, 94109, United States

Location

GSK Investigational Site

Bradenton, Florida, 34209, United States

Location

GSK Investigational Site

Chipley, Florida, 32428, United States

Location

GSK Investigational Site

Daytona Beach, Florida, 32117, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33916, United States

Location

GSK Investigational Site

Gainesville, Florida, 32608, United States

Location

GSK Investigational Site

Marianna, Florida, 32446, United States

Location

GSK Investigational Site

Miami Springs, Florida, 33166, United States

Location

GSK Investigational Site

Naranja, Florida, 33032, United States

Location

GSK Investigational Site

South Miami, Florida, 33143, 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, 33612, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Marietta, Georgia, 30060, United States

Location

GSK Investigational Site

Chicago, Illinois, 60617, United States

Location

GSK Investigational Site

Terre Haute, Indiana, 47802, 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

Missoula, Montana, 59808, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03766, United States

Location

GSK Investigational Site

New York, New York, 10004, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, 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

Norman, Oklahoma, 73071, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Medford, Oregon, 97501, United States

Location

GSK Investigational Site

Greensburg, Pennsylvania, 15601, United States

Location

GSK Investigational Site

Kingsport, Tennessee, 37660, United States

Location

GSK Investigational Site

Austin, Texas, 78756, United States

Location

GSK Investigational Site

Houston, Texas, 77028, United States

Location

GSK Investigational Site

Houston, Texas, 77044, United States

Location

GSK Investigational Site

Houston, Texas, 77089, United States

Location

GSK Investigational Site

Longview, Texas, 75605, 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

Yakima, Washington, 98902, United States

Location

GSK Investigational Site

Schönau, Baden-Wurttemberg, 69250, Germany

Location

GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

Location

GSK Investigational Site

Wiesbaden, Hesse, 65189, Germany

Location

GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44892, Germany

Location

GSK Investigational Site

Hattingen, North Rhine-Westphalia, 45525, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Leipzg, Saxony, 04109, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10409, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10435, Germany

Location

Related Publications (1)

• Harden RN, Freeman R, Rainka M, Zhang L, Bell C, Berges A, Chen C, Graff O, Harding K, Hunter S, Kavanagh S, Schwartzbach C, Warren S, McClung C. A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. Pain Med. 2013 Dec;14(12):1918-32. doi: 10.1111/pme.12227. Epub 2013 Sep 18.

  PMID: 24102928 DERIVED

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: March 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

US (42); DE (11)