Trial Outcomes & Findings for A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) (NCT NCT00619476)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

376 participants

Primary outcome timeframe

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

Results posted on

2013-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	95	107	84	90
Overall Study Intent-to-Treat Population	95	107	82	87
Overall Study Safety Population	95	107	82	87
Overall Study COMPLETED	64	85	60	56
Overall Study NOT COMPLETED	31	22	24	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Adverse Event	12	6	12	16
Overall Study Lack of Efficacy	6	1	1	4
Overall Study Protocol Violation	5	4	4	9
Overall Study Lost to Follow-up	1	2	0	1
Overall Study Investigator Discretion	2	2	2	0
Overall Study Withdrawal by Subject	5	7	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=82 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)	Total n=371 Participants Total of all reporting groups
Age Continuous	61.7 Years STANDARD_DEVIATION 12.77 • n=5 Participants	61.7 Years STANDARD_DEVIATION 12.58 • n=7 Participants	64.1 Years STANDARD_DEVIATION 8.94 • n=5 Participants	61.3 Years STANDARD_DEVIATION 15.41 • n=4 Participants	62.1 Years STANDARD_DEVIATION 12.67 • n=21 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	54 Participants n=7 Participants	35 Participants n=5 Participants	48 Participants n=4 Participants	182 Participants n=21 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	53 Participants n=7 Participants	47 Participants n=5 Participants	39 Participants n=4 Participants	189 Participants n=21 Participants
Race/Ethnicity, Customized White	79 participants n=5 Participants	94 participants n=7 Participants	69 participants n=5 Participants	73 participants n=4 Participants	315 participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	14 participants n=5 Participants	11 participants n=7 Participants	8 participants n=5 Participants	11 participants n=4 Participants	44 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Asian - Japanese/ East Asian Heritage	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Not Provided	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants

PRIMARY outcome

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

Population: ITT Population: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=82 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
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	-1.66 points on a scale Standard Error 0.216	-2.47 points on a scale Standard Error 0.204	-2.36 points on a scale Standard Error 0.237	-2.72 points on a scale Standard Error 0.227

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint.

Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=81 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=86 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data	-1.65 points on a scale Standard Error 0.219	-2.35 points on a scale Standard Error 0.206	-2.44 points on a scale Standard Error 0.238	-2.50 points on a scale Standard Error 0.231

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.

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 EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=81 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=86 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data	-1.34 points on a scale Standard Error 0.223	-2.29 points on a scale Standard Error 0.209	-2.13 points on a scale Standard Error 0.242	-2.41 points on a scale Standard Error 0.234

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.

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

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=81 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=86 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data	-1.76 points on a scale Standard Error 0.239	-2.49 points on a scale Standard Error 0.225	-2.65 points on a scale Standard Error 0.260	-2.71 points on a scale Standard Error 0.252

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint.

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 EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=81 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=86 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data	-2.04 points on a scale Standard Error 0.225	-2.72 points on a scale Standard Error 0.212	-2.58 points on a scale Standard Error 0.245	-2.78 points on a scale Standard Error 0.237

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint.

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 EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=106 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=80 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data	-1.59 points on a scale Standard Error 0.218	-2.47 points on a scale Standard Error 0.206	-2.23 points on a scale Standard Error 0.239	-2.67 points on a scale Standard Error 0.229

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint.

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 EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=106 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=80 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data	-1.45 points on a scale Standard Error 0.225	-2.45 points on a scale Standard Error 0.213	-2.24 points on a scale Standard Error 0.247	-2.69 points on a scale Standard Error 0.236

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint.

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

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=106 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=80 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data	-1.74 points on a scale Standard Error 0.242	-2.61 points on a scale Standard Error 0.229	-2.41 points on a scale Standard Error 0.265	-2.82 points on a scale Standard Error 0.253

SECONDARY outcome

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

Population: ITT Population. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal.

The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=102 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=74 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=77 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data NPS 10 Score	-17.17 points on a scale Standard Error 2.094	-22.78 points on a scale Standard Error 1.907	-24.02 points on a scale Standard Error 2.256	-25.2 points on a scale Standard Error 2.202
Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data NPS 8 Score	-17.05 points on a scale Standard Error 2.059	-22.23 points on a scale Standard Error 1.875	-23.77 points on a scale Standard Error 2.217	-24.49 points on a scale Standard Error 2.165
Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data NPS Non-Allodynic Score	-16.87 points on a scale Standard Error 2.107	-22.58 points on a scale Standard Error 1.920	-24.18 points on a scale Standard Error 2.269	-24.54 points on a scale Standard Error 2.216
Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data NPS 4 Score	-18.25 points on a scale Standard Error 2.340	-24.37 points on a scale Standard Error 2.133	-26.08 points on a scale Standard Error 2.519	-26.55 points on a scale Standard Error 2.464

SECONDARY outcome

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

Population: ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit.

The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=101 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=74 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=76 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data SF-MPQ Total Score	-6.08 points on a scale Standard Error 0.949	-8.35 points on a scale Standard Error 0.869	-7.45 points on a scale Standard Error 1.024	-8.15 points on a scale Standard Error 1.006
Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data SF-MPQ Sensory Score	-4.51 points on a scale Standard Error 0.737	-6.07 points on a scale Standard Error 0.675	-5.43 points on a scale Standard Error 0.795	-6.13 points on a scale Standard Error 0.782
Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data SF-MPQ Affective Score	-1.58 points on a scale Standard Error 0.270	-2.27 points on a scale Standard Error 0.247	-2.08 points on a scale Standard Error 0.291	-1.99 points on a scale Standard Error 0.286

SECONDARY outcome

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

Population: ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit.

Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=100 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=73 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=74 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data	-2.29 points on a scale Standard Error 0.150	-1.97 points on a scale Standard Error 0.137	-2.16 points on a scale Standard Error 0.161	-2.25 points on a scale Standard Error 0.161

SECONDARY outcome

Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Population: ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.

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." EOMT response is defined as the score recorded at the Week13/Withdrawal visit.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=103 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=78 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=76 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data	24 participants	45 participants	35 participants	39 participants

SECONDARY outcome

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

Population: ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction.

Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the \[(EOMT score minus the baseline score)divided by the baseline score\], 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.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=106 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=81 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
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 >= 30% reduction from baseline	40 participants	57 participants	48 participants	52 participants
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 >=0 reducation from baseline	79 participants	94 participants	71 participants	84 participants
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 >= 10% reduction from baseline	62 participants	83 participants	61 participants	70 participants
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 >= 20% reduction from baseline	50 participants	71 participants	55 participants	65 participants
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 >= 40% reduction from baseline	32 participants	50 participants	39 participants	46 participants
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 >= 50% reduction from baseline	22 participants	44 participants	28 participants	37 participants
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 >= 60% reduction from baseline	15 participants	34 participants	14 participants	31 participants
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 >= 70% reduction from baseline	9 participants	25 participants	18 participants	24 participants
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 >= 80% reduction from baseline	8 participants	17 participants	12 participants	19 participants
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 >= 90% reduction from baseline	3 participants	9 participants	9 participants	12 participants
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 100% reduction from baseline	1 participants	6 participants	3 participants	7 participants

SECONDARY outcome

Timeframe: Anytime post-baseline until date of last dose of study medication (up to Week 13)

Population: ITT Population

Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is \>=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as the first day of event minus the last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=107 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=82 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score	49 days Interval 2.0 to 86.0	27 days Interval 1.0 to 96.0	10 days Interval 1.0 to 79.0	10 days Interval 1.0 to 67.0

SECONDARY outcome

Timeframe: Baseline and EOMT (Week 13 or early withdrawal)

Population: ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment.

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

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants 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 n=106 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=80 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data	-41.00 milligrams Standard Error 89.488	-289.94 milligrams Standard Error 84.350	-260.03 milligrams Standard Error 97.853	-266.21 milligrams Standard Error 93.503

SECONDARY outcome

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

Population: ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.

The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 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 each summary score ranges from 0 to 10 (0=no impact and 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=101 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=74 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=76 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
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 Brief Pain Inventory Severity of Pain	-1.8 points on a scale Standard Error 0.22	-2.4 points on a scale Standard Error 0.20	-2.4 points on a scale Standard Error 0.24	-2.5 points on a scale Standard Error 0.24
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 Brief Pain Inventory Interference of Pain	-2.0 points on a scale Standard Error 0.20	-2.2 points on a scale Standard Error 0.19	-2.2 points on a scale Standard Error 0.22	-2.3 points on a scale Standard Error 0.22

SECONDARY outcome

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

Population: ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.

The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=101 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=74 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=75 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data SF-36 Mental Component Summary Score	3.2 points on a scale Standard Error 0.92	5.1 points on a scale Standard Error 0.85	4.5 points on a scale Standard Error 0.99	5.8 points on a scale Standard Error 0.99
Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data SF-36 Physical Component Summary Score	3.3 points on a scale Standard Error 0.74	4.3 points on a scale Standard Error 0.67	4.4 points on a scale Standard Error 0.79	4.9 points on a scale Standard Error 0.78

SECONDARY outcome

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

Population: ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.

The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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 n=101 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=74 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=75 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Anger/Hostility Domain Score	-1.6 points on a scale Standard Error 0.29	-2.0 points on a scale Standard Error 0.27	-2.4 points on a scale Standard Error 0.31	-1.7 points on a scale Standard Error 0.31
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Fatigue/Inertia Domain Score	-1.4 points on a scale Standard Error 0.40	-1.9 points on a scale Standard Error 0.37	-2.4 points on a scale Standard Error 0.43	-2.5 points on a scale Standard Error 0.43
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Tension/Anxiety Domain Score	-1.6 points on a scale Standard Error 0.29	-1.8 points on a scale Standard Error 0.26	-2.0 points on a scale Standard Error 0.30	-2.0 points on a scale Standard Error 0.30
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Depression/Rejection Domain Score	-1.4 points on a scale Standard Error 0.28	-1.5 points on a scale Standard Error 0.26	-1.9 points on a scale Standard Error 0.30	-1.7 points on a scale Standard Error 0.30
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Vigor/Activity Domain Score	0.4 points on a scale Standard Error 0.38	0.8 points on a scale Standard Error 0.35	0.5 points on a scale Standard Error 0.41	1.4 points on a scale Standard Error 0.41
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data Confusion/Bewilderment Domain Score	-0.7 points on a scale Standard Error 0.25	-0.5 points on a scale Standard Error 0.22	-1.0 points on a scale Standard Error 0.26	-0.5 points on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Population: ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.

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." EOMT response is defined as the score recorded at the Week13/Withdrawal visit.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants 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 n=85 Participants One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=68 Participants Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=68 Participants Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data	21 participants	38 participants	34 participants	33 participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

GEn 1200 mg/Day

Serious events: 0 serious events

Other events: 75 other events

Deaths: 0 deaths

GEn 2400 mg/Day

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

GEn 3600 mg/Day

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=120 participants at risk；n=95 participants at risk 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 n=107 participants at risk One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)	GEn 2400 mg/Day n=82 participants at risk Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)	GEn 3600 mg/Day n=87 participants at risk Three 600 mg GEn tablets taken orally twice daily (morning and evening)
Nervous system disorders Intracranial Aneruysm	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Nervous system disorders Multiple Sclerosis	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Cardiac disorders Atrial Fibrillation	1.1% 1/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Gastrointestinal disorders Gastritis	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.1% 1/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
General disorders Chest Pain	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Infections and infestations Sinusitis	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Injury, poisoning and procedural complications Vascular Injury	1.1% 1/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Investigations Blood Pressure Increased	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Psychiatric disorders Anxiety	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.2% 1/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.
Reproductive system and breast disorders Cystocele	0.00% 0/95 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/107 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	0.00% 0/82 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.	1.1% 1/87 Adverse Events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, which was comprised of all randomized participants who took at least one dose of investigational product.

Other adverse events

Additional Information

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Phone: 877-936-6778

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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