CTRI/2020/11/029275尚未招募3 期
Pregabalin for chronic cough in patients with lung cancer: a randomized doubleblind placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age 18 years or older.
- •2.Locally advanced or metastatic suspected or
- •diagnosed NSCLC.
- •3.Eastern Cooperative Group performance status
- •between 0 and 2.
- •4.Moderate (grade 2) or severe (grade 3) cough
- •that has lasted for 2 or more weeks. Cough
- •severity will be according to the Common
- •Terminology Criteria for Adverse Events
- •(CTCAE), v.5, in which grade 2 signifies
- •moderate symptoms, medical intervention
- •required, limiting instrumental activities of
- •daily living; and grade 3 cough signifies
- •severe symptoms limiting self-care activities
- •of daily living.
- •5.Willing and able to limit to one alcoholic
- •beverage per day (e.g. 360 ml of beer or 120
- •ml of wine or 330 ml of cooler or 43 ml of
- •hard liquor like whisky/ vodka/ rum/ gin).
- •6.Creatinine clearance measured by the
- •Cockcroft-Gault formula > 60 ml/min.
- •7.Women of childbearing potential must be
- •willing to consent to using effective
- •contraception (e.g.,hormonal contraceptives,
- •bilateral tubal ligation, barrier with
- •spermicide, intrauterine device) while on
- •treatment and for at least 3 months
- •thereafter. A man who is the partner of a
- •woman of childbearing potential must be
- •willing to consent to using effective
- •contraception (e.g., vasectomy or barrier
- •with spermicide) while on treatment and for 3
- •months thereafter.
- •8.Capable of providing informed consent and
- •follow trial procedures.
排除标准
- •1.Patients already receiving pregabalin or
- •gabapentin, irrespective of indication, at the
- •time of screening.
- •2.Known hypersensitivity to pregabalin or
- •gabapentin or their components.
- •3.Pregnancy or breast feeding.
研究者
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