NCT01049217终止3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.63 个研究点 分布在 8 个国家目标入组 377 人开始时间: 2010年4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
- 终止
- 发起方
- 入组人数
- 377
- 试验地点
- 63
- 主要终点
- Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
详细描述
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
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, Care Provider, Investigator)
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
- •Men and women, ages of 18 or greater
- •Documented evidence of HIV-1 infection
- •Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
- •Pain starts in the feet
排除标准
- •Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
- •Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9
- •Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy
研究组 & 干预措施
Active drug
Experimental
干预措施: pregabalin (Drug)
Control
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)
时间窗: Baseline, Endpoint (up to Week 16)
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).
次要结局
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)(Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16))
- Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire(Baseline, Week 16, 17)
- Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)(Week 16)
- Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16))
- Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Total Activity Counts(Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16))
- Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16))
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)(Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16))
- Sleep Efficiency(Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16))
- Percentage Day Time Above Sedentary Level(Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16))
- Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)(Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)(Baseline, Endpoint (up to Week 16))
- Sleep Fragmentation Index (SFI)(Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16))
- Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep(Baseline, Endpoint (up to Week 16))
- Diagnostic Neuropathy Assessment(Screening)
- Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire(Baseline, Week 16, 17)
- Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire(Baseline, Week 16, 17)
研究者
研究点 (63)
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