A Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Saliva Secreted Rate
研究概览
简要总结
The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with excessive salivation.
详细描述
Sialorrhea is excessive flow of saliva associated with its unintentional loss from the mouth, commonly known as drooling. Sialorrhea may result from any combination of hypersecretion, problems swallowing or sensorimotor problems containing saliva in the mouth. It is commonly found in people with neurological dysfunction such as Parkinson's Disease, leading to social isolation and embarrassment. In general, treatment options are limited because of the underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC Oral solution is to develop a new treatment option that can be used to titrate saliva secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling) but not so low as to cause an uncomfortably dry mouth.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease for at least 2 years
- •Patients with a score of ≥2 on the salivation section of UPDRS, item 6
- •Patients Hoehn and Yahr stage must be ≤4
- •under stable anti-Parkinson therapy throughout the study
- •Able and willing to comply with the study procedures
- •Able to provide and provision of a written informed consent
排除标准
- •Female who is pregnant/lactating or planning to be pregnant
- •Must not have a form of drug-induced or atypical parkinsonism or parkinsonism with swallow problems due to other etiology
- •Have current uncontrolled hypertension, symptomatic postural hypotension, active Raynaud's disease or other peripheral vascular occlusive disease
- •Have a history or presence of hyperthyroidism, congestive heart failure, coronary heart disease, cardiac arrhythmias, tachycardia or severe bradycardia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree
- •Have a history of narrow angle glaucoma or shallow anterior chamber
- •Have a history or presence of gastrointestinal obstruction, including paralytic ileus and intestinal atony or gastrointestinal motility disorders, toxic megacolon or severe ulcerative colitis
- •Have a history or presence of bladder outflow obstruction or urinary retention
- •Patients with hepatic or renal impairment
- •Male with QTc > 430 ms or female with QTc > 450 ms ECG results at screening
- •Concomitant use of α2-agonist, anticholinergic medication or other medications that affect ACh levels
- •Have a history of alcohol or substance abuse
- •Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
- •Have a history of hypersensitivity to the investigational medicinal product or any of the excipients or to medicinal products with similar chemical structures
- •Have received treatment with any other investigational medicinal product in the last 6 weeks before administration of the first dose in this clinical study
- •Have received treatment with any medicinal product known to have a well-defined potential for toxicity to a major organ in the previous 3 months
- •Have a positive result of the human immunodeficiency virus (HIV) 1 and 2 test
- •Have problems to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study
- •Are unlikely to comply with the protocol requirements, instructions and study related restrictions
- •Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the clinical study
- •Vulnerable subjects
- •Have any concurrent disease or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the clinical study
- •Donation of 500 ml or more of blood within the last 8 weeks before start of the study and for at least 4 weeks after study completion
- •Have previously been enrolled in this clinical study
- •Vulnerable subjects
研究组 & 干预措施
oxybutynin and clonidine oral solution treatment D
Placebo
干预措施: oxybutynin and clonidine oral solution treatment D (Drug)
oxybutynin and clonidine oral solution treatment C
High dose oxybutynin and clonidine
干预措施: oxybutynin and clonidine oral solution treatment C (Drug)
oxybutynin and clonidine oral solution treatment A
Low dose oxybutynin and clonidine
干预措施: oxybutynin and clonidine oral solution treatment A (Drug)
oxybutynin and clonidine oral solution treatment B
Intermediate dose oxybutynin and clonidine
干预措施: oxybutynin and clonidine oral solution treatment B (Drug)
结局指标
主要结局
Saliva Secreted Rate
时间窗: 8 hours post-dose
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
次要结局
- Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production(8 hours post-dose)
- Evaluation of the Safety and Tolerability of Different Combinations of Oxybutynin and Clonidine (OC Oral Solution) in Patients Suffering From Parkinson's Disease With Excessive Salivation(during the study treatment period and follow up period at least 23 days excluding the screening period.)