NCT02504008Unknown3 期
CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 190
- 主要终点
- Change in patient reported pain intensity
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.
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
- Double (Participant, 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
- •Male or female of at least 18 years of age
- •Recently confirmed diagnosis of CRPS-1 (Budapest criteria)
- •Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])
- •Willing and able to provide written informed consent
排除标准
- •Received chronic opioid therapy within 4 weeks
- •Received a sympathetic nerve block within 3 weeks
- •Active litigation or a pending workers' compensation decision
- •Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study
研究组 & 干预措施
AXS-02 (oral zoledronate)
Experimental
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
干预措施: AXS-02 (oral zoledronate) (Drug)
Placebo
Placebo Comparator
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
干预措施: Placebo (Drug)
结局指标
主要结局
Change in patient reported pain intensity
时间窗: Baseline to Week 12
Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible).
次要结局
- Change in Brief Pain Inventory (BPI) Pain Score(Baseline to Week 12)
- Patients' Global Impression of Change (PGI-C)(Baseline to Week 12)
- Clinicians' Global Impression of Change (CGI-C)(Baseline to Week 12)
- Change in EuroQOL 5-dimensions questionnaire (EQ-5D)(Baseline to Week 12)
- Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)(Baseline to Week 12)
- Change in bone turnover markers(Baseline to Week 52)
研究者
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