Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
研究概览
简要总结
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)
详细描述
This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Pregabalin
Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks
干预措施: Pregabalin (Drug)
GEn 1200mg/day
gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks
干预措施: GEn 1200mg/day (Drug)
GEn 2400mg/day
gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks
干预措施: GEn 2400mg/day (Drug)
GEn 3600mg/day
gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks
干预措施: GEn 3600mg/day (Drug)
结局指标
主要结局
Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
时间窗: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
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 API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (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. Change from baseline was calculated as the EOMT score minus the Baseline score.
次要结局
- Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data(EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data(EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- 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(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score(Any time post-baseline until date of last dose of study medication (up to Week 13))
- 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(Baseline and EOMT)
- Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
- Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))