NCT00232141已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
研究概览
简要总结
Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
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
- Quadruple (Participant, Care Provider, 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
- •Subjects with confirmed diagnosis of HIV infection
- •HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
- •subjects with moderate to severe pain
- •subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).
排除标准
- •Pregnant or breast feeding females
- •subjects using street drugs or alcohol abusers during the study
- •subject's on anti-diabetic medications
- •use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
- •use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.
研究组 & 干预措施
1
Experimental
干预措施: pregabalin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
时间窗: Baseline, Week 14
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Change From Baseline for NRS-Sleep Interference Scores(Baseline, Week 14)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)(Baseline, Week 14)
- Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)(Baseline, Week 14)
- Gracely Pain Scale Score(Week 14)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Patient Global Impression of Change (PGIC) Rating(Baseline, Week 14, Endpoint-LOCF)
- Change in Quantitative Assessment of Neuropathic Pain (QANeP)(Baseline, Week 14)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores(Baseline, Week 14)
- Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table(Baseline-Week 14 (Endpoint))
- Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table(Baseline-Week 14 (Endpoint))
- Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices(Baseline, Week 14)
- Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales(Baseline, Week 14)
- Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores(Baseline, Week 14)
- Categorized Patient Global Impression of Change (PGIC)(Baseline, Week 14)
- Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)(Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks(Baseline-Week 14 (Endpoint))
- Change in NRS-Sleep Interference Scores(Baseline, Weeks 1-14)
- Shift in Hospital Anxiety and Depression (HADS) Subscales(Baseline, Week 14)
- Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)(Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)(Baseline, Weeks 1,2,6,10,14 and Endpoint)
- Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain(Baseline-Week 14 (Endpoint))
研究者
研究点 (1)
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