NCT01667029终止2 期
A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pain Score (First Treatment Period)
研究概览
简要总结
The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Painful neuropathy
- •Michigan Neuropathy Screening Instrument score of 3 or greater
- •no obvious alternative explanation for neuropathy
- •average baseline pain > 4/10
排除标准
- •other severe pain
- •anticipated difficulty weaning off medications
- •past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
- •medical contraindication to sulfasalazine
- •not proficient in English (due to heavy use of questionaires)
- •pregnant or breast feeding women
研究组 & 干预措施
sulfasalazine
Experimental
1 g oral twice daily for 2 weeks
干预措施: Sulfasalazine (Drug)
placebo
Placebo Comparator
oral placebo pill twice daily for two weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Pain Score (First Treatment Period)
时间窗: second week of two week treatment period
Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).
次要结局
- Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Emotional Functioning (First Treatment Period Only)(Assessed at end of two week treatment period)
- Overall Improvement (First Treatment Period Only)(Will be assessed at end of two week treatment period)
- Pain Score (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)(Assessed at end of two week treatment period)
- Categorical Rating of Pain Intensity (First Treatment Period Only)(Assessed at end of two week treatment period)
- Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)(Assessed during two week treatment period)
- Missed Medication Doses (Using the Crossover Comparison Structure of the Study)(Assessed during two week treatment period)
- Number of Patients With >=50% Pain Reduction (First Treatment Period)(second week of two week treatment period)
- Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)(Assessed at end of two week treatment period)
- Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Overall Improvement (Using the Crossover Comparison Structure of the Study)(Will be assessed at end of two week treatment period)
- Emotional Functioning (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)(Assessed at end of two week treatment period)
- Breakthrough Treatment (First Treatment Period Only)(Assessed during two week treatment period)
- Missed Medication Dose (First Treatment Period Only)(Assessed during two week treatment period)
研究者
Brian Wainger
Principal Investigator
Massachusetts General Hospital
研究点 (1)
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