NCT00592098已完成2 期
A Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Persistent, Moderate-to-Severe Lower Limb Post-Amputation Stump Pain.
SantoSolve AS1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
研究概览
简要总结
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
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
- •Lower limb amputation at least 6 months prior to inclusion
- •Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS
- •Outpatients, aged 18 years and above
- •Written informed consent
排除标准
- •Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation)
- •Subjects taking any analgesic medication (except for rescue medication as defined in this protocol)
- •Subjects with expressed dissatisfaction with their prosthesis comfort
- •Pregnant or breast-feeding women
- •Any malignant disease
- •Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry.
- •Subjects unable to comply with the study assessments
- •Subjects with documented or suspected alcohol or drug abuse
研究组 & 干预措施
1
Experimental
2PX
干预措施: Strontium chloride hexahydrate (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
时间窗: 24 hours
次要结局
- • Worst Pain Intensity (WPI)(24 hours)
- • Pain relief(Weekly)
- • Sleep disturbance(24 hours)
- • Use of rescue medication(Daily)
- • Patient Global Impression of Change (PGIC)(Weekly)
- • Prosthesis bothersomeness(Weekly)
- • Quality of life assessment(Q 14 days)
- Local skin irritability(Q 14 days)
- Adverse events(Q 14 days)
研究者
研究点 (1)
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