Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- discontinuation of medication
研究概览
简要总结
The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.
详细描述
Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods
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, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy)
- •Adult patients aged 19 to 85 years
- •Patients who pre-agreed to the study
排除标准
- •Patients complaining of severe pain (NRS ≥ 8)
- •Creatinine clearance of <30 mL / min, the liver was more than 3 times normal
- •Patients complaining of dizziness, patients with definite orthostatic hypotension
- •Pregnant or lactating patients
- •Patients who previously experienced side effects after administration pregabalin.
研究组 & 干预措施
Pregabalin 75mg bid
The patients who were prescribed according to the conventional flexible dose regimen
干预措施: Pregabalin 75mg bid (Drug)
pregabalin 25mg,50mg
The patients who were prescribed according to the new flexible dose regimen.
干预措施: Pregabalin 25mg, 50mg (Drug)
结局指标
主要结局
discontinuation of medication
时间窗: After 7 weeks of prescription
the portion of patients discontinuing medication
次要结局
未报告次要终点
研究者
Kyoung-Ho Ryu, MD
Assistant Professor
Kangbuk Samsung Hospital