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

Primary Purpose

Neuralgia, Postherpetic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GEn 1200mg/day

GEn 3600mg/day

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic focused on measuring Post-herpetic neuralgia(PHN), Neuropathic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GEn 1200mg/day

GEn 3600mg/day

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of 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

Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

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

Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of 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

Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

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

Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.

Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period

Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.

Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period

Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data

The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved" Data are summarized by dose, independent of treatment period.

Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved". Data are summarized by dose within each treatment period.

Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data

The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." Data are summarized by dose, independent of treatment period.

Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data

Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF

The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.

Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations

Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as "Full Range." A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured.

Full Information

NCT ID

NCT00617461

First Posted

February 6, 2008

Last Updated

July 15, 2013

Sponsor

XenoPort, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00617461

Brief Title

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

Official Title

Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XenoPort, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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 history of an inadequate response to gabapentin treatment. The study is a cross-over design. Prior to screening subjects are required to have a demonstrated history of an inadequate response (as determined by the investigator) to at least 1800 mg/day of gabapentin. Prior history of treatment with gabapentin includes current treatment at 1800mg/day (2 weeks) or prior treatment with ≥1800mg/day (4 weeks). Subjects could also have been treated with pregabalin monotherapy (150-300mg/day, ≥4 weeks) and had an inadequate response. Subjects are treated with gabapentin 1800mg/day during the Baseline Period and are randomized if during the Basleline Period they are compliant with gabapentin treatment and have a 24-hour average pain intensity score ≥4.0 based on an 11-point pain intensity numerical rating scale (PI-NRS). Subjects are then randomized to receive gabapentin enacarbil (either 1200mg/day or 3600mg/day in a 1:1 ratio) for Treatment Period 1 (28 days). Followed by a dose of 2400mg/day for 4 days and the alternate fixed dose (either 3600 mg/day or 1200 mg/day) for Treatment Period 2 (28 days).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia, Postherpetic

Keywords

Post-herpetic neuralgia(PHN), Neuropathic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GEn 1200mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

GEn 3600mg/day

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GEn 1200mg/day

Other Intervention Name(s)

GEn, XP13512/GSK1838262, gabapentin enacarbil

Intervention Description

1200mg/day gabapentin enacarbil

Intervention Type

Drug

Intervention Name(s)

GEn 3600mg/day

Other Intervention Name(s)

gabapentin enacarbil, GEn, XP13512/GSK1838262

Intervention Description

3600mg/day gabapentin enacarbil

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

Description

Time Frame

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

Title

Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

Description

Time Frame

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

Title

Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period

Description

Time Frame

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

Title

Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period

Description

Time Frame

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

Title

Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data

Description

Time Frame

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

Title

Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

Description

The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved". Data are summarized by dose within each treatment period.

Time Frame

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

Title

Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data

Description

Time Frame

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

Title

Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

Description

Time Frame

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

Title

Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data

Description

Time Frame

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

Title

Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF

Description

Time Frame

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

Title

Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations

Description

Time Frame

A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

GSK Investigational Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

GSK Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

GSK Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

GSK Investigational Site

City

Chipley

State/Province

Florida

ZIP/Postal Code

32428

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

GSK Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

GSK Investigational Site

City

Marianna

State/Province

Florida

ZIP/Postal Code

32446

Country

United States

Facility Name

GSK Investigational Site

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

GSK Investigational Site

City

Naranja

State/Province

Florida

ZIP/Postal Code

33032

Country

United States

Facility Name

GSK Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

GSK Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

GSK Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60617

Country

United States

Facility Name

GSK Investigational Site

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

GSK Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

GSK Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

GSK Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03766

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10004

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

GSK Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

GSK Investigational Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97501

Country

United States

Facility Name

GSK Investigational Site

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

Facility Name

GSK Investigational Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77028

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77044

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

GSK Investigational Site

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78238

Country

United States

Facility Name

GSK Investigational Site

City

Weber City

State/Province

Virginia

ZIP/Postal Code

24290

Country

United States

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

GSK Investigational Site

City

Yakima

State/Province

Washington

ZIP/Postal Code

98902

Country

United States

Facility Name

GSK Investigational Site

City

Schoenau

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69250

Country

Germany

Facility Name

GSK Investigational Site

City

Huettenberg

State/Province

Hessen

ZIP/Postal Code

35625

Country

Germany

Facility Name

GSK Investigational Site

City

Wiesbaden

State/Province

Hessen

ZIP/Postal Code

65189

Country

Germany

Facility Name

GSK Investigational Site

City

Achim

State/Province

Niedersachsen

ZIP/Postal Code

28832

Country

Germany

Facility Name

GSK Investigational Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44892

Country

Germany

Facility Name

GSK Investigational Site

City

Hattingen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45525

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55116

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzg

State/Province

Sachsen

ZIP/Postal Code

04109

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10409

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24102928

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Neuralgia, Postherpetic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial