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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Neuralgia, Postherpetic
Interventions:	Drug: GEn 1200mg/day Drug: GEn 2400mg/day Drug: GEn 3600mg/day Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
GEn 1200 mg/Day	One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
GEn 2400 mg/Day	Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
GEn 3600 mg/Day	Three 600 mg GEn tablets taken orally twice daily (morning and evening)

Participant Flow: Overall Study

	Placebo	GEn 1200 mg/Day	GEn 2400 mg/Day	GEn 3600 mg/Day
STARTED	95	107	84	90
Intent-to-Treat Population	95	107	82	87
Safety Population	95	107	82	87
COMPLETED	64	85	60	56
NOT COMPLETED	31	22	24	34
Adverse Event	12	6	12	16
Lack of Efficacy	6	1	1	4
Protocol Violation	5	4	4	9
Lost to Follow-up	1	2	0	1
Investigator Discretion	2	2	2	0
Withdrawal by Subject	5	7	5	4

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
GEn 1200 mg/Day	One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
GEn 2400 mg/Day	Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
GEn 3600 mg/Day	Three 600 mg GEn tablets taken orally twice daily (morning and evening)

Baseline Measures

	Placebo	GEn 1200 mg/Day	GEn 2400 mg/Day	GEn 3600 mg/Day	Total
Number of Participants [units: participants]	95	107	82	87	371
Age ^[1] [units: Years] Mean ± Standard Deviation	61.7 ± 12.77	61.7 ± 12.58	64.1 ± 8.94	61.3 ± 15.41	62.1 ± 12.67
Gender ^[2] [units: Participants]
Female	45	54	35	48	182
Male	50	53	47	39	189
Race/Ethnicity, Customized ^[3] [units: participants]
White	79	94	69	73	315
African American/African Heritage	14	11	8	11	44
American Indian or Alaskan Native	0	0	2	1	3
Asian - Central/South Asian Heritage	1	0	1	0	2
Asian - Japanese/ East Asian Heritage	0	1	1	1	3
Native Hawaiian or other Pacific Islander	0	0	0	1	1
Not Provided	1	1	1	0	3

[1]	Age in years of the Intent-to-Treat (ITT) Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics.
[2]	Gender of the ITT Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics.
[3]	Race of the ITT Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics.

Outcome Measures

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1. Primary:

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 [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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2. Secondary:

Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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3. Secondary:

Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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4. Secondary:

Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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5. Secondary:

Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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6. Secondary:

Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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7. Secondary:

Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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8. Secondary:

Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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9. Secondary:

Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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10. Secondary:

Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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11. Secondary:

Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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12. Secondary:

Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data [ Time Frame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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13. Secondary:

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 [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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14. Secondary:

Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score [ Time Frame: Anytime post-baseline until date of last dose of study medication (up to Week 13) ]

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15. Secondary:

Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (Week 13 or early withdrawal) ]

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16. Secondary:

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 [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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17. Secondary:

Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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18. Secondary:

Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data [ Time Frame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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19. Secondary:

Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00619476 History of Changes
Other Study ID Numbers:	110748
Study First Received:	February 7, 2008
Results First Received:	April 26, 2011
Last Updated:	October 13, 2011
Health Authority:	Canada: Health Canada United States: Food and Drug Administration