NCT02613494已完成1 期
A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine
Mersey Care NHS Trust2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年1月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of participants recruited and number of participants finishing the study
研究概览
简要总结
A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in a multi-centre trial.
详细描述
Primary objective
To assess the feasibility of recruiting both community and in-patients from different centres. Specifically, the feasibility study will:
- Ascertain whether the study design is acceptable to participants, including randomisation and use of telephone interviews.
- Ascertain whether the interventions are acceptable to participants and indicate likely attrition rates and tolerability.
Secondary objective
Ascertain the standard deviation of the daytime hypersalivation measure to estimate the required sample size for a future efficacy randomised clinical trial (RCT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed clozapine for a minimum of three months.
- •Is experiencing hypersalivation (minimum score of 4 on the Drooling Rating Scale).
- •Aged between 18 and 65 years and English speaking.
- •Is capable of understanding the information given and provides informed consent prior to study specific procedures.
排除标准
- •Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson's Disease).
- •Neurological conditions that could affect cognitive functioning during the course of the study (e.g. unstable epilepsy)
- •History of an allergic reaction to hyoscine hydrobromide or glycopyrrolate.
- •Any of the following contra-indications to hyoscine or glycopyrrolate as stated in the British National Formulary: prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, toxic megacolon.
- •Any of the following cautions to hyoscine or glycopyrrolate as stated in the British National Formulary e.g. closed angle glaucoma, chronic heart failure, chronic lung disease, untreated stomach ulcer, ulcerative colitis, significant liver problems, significant kidney disease, Downs Syndrome, persistent untreated tachycardia, overactive thyroid gland.
- •Current prescription for potassium chloride, digoxin, cimetidine, indacaterol, amantadine, atenolol, levodopa or medications that, in the view of the trial pharmacist, have a significant anticholinergic profile.
- •A woman of childbearing potential who has tested negative for pregnancy, unable or unwilling to use contraception during the study.
- •Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
- •Active suicidal ideation.
- •Lack of capacity to provide informed consent. -
研究组 & 干预措施
Hyoscine
Active Comparator
Hyoscine hydrobromide
干预措施: Hyoscine (Drug)
Glycopyrrolate
Active Comparator
Glycopyrronium bromide
干预措施: Glycopyrrolate (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants recruited and number of participants finishing the study
时间窗: Assessed at the end of the study (20 months after start of study)
次要结局
- Standard deviation of the daytime hypersalivation measure assessed by the Drooling Rating Scale (DRS)(Assessed at the end of the study (20 months after start of study))
研究者
研究点 (2)
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