Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 5
- 主要终点
- Change in the Nepean dyspepsia index-Korean version scores
研究概览
简要总结
The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe for the treatment on health-related quality of life in Parkinson's disease (PD) patients with gastrointestinal symptoms.
详细描述
Gastrointestinal (GI) symptoms are frequently complained by PD patients. To improve their symptoms, prokinetics are often used in clinics. However, some prokinetics are dopamine receptor antagonist which can aggravate motor symptoms of PD patients or develop tardive dyskinesia when it affects dopamine receptors of the brain.
DA-9701 (Motilitone) is recently developed herbal medication which has both 5-HT4 agonism and D2 antagonism. Furthermore, it does not cross the blood brain barrier that can be safely used in PD patients. Hypothetically it has a potential to be a good choice for the treatment of GI symptoms of PD patients. However, there has been no study that evaluates its efficacy and safety by randomized clinical trials in PD patients.
This study will evaluate the efficacy and safety of DA-9701 in the double-blind placebo-controlled phase 1 (4 weeks), and the long-term safety of DA-9701 in the open-label phase 2 (8 weeks after phase 1).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were enrolled voluntarily and understood the contents of this clinical trial.
- •Male or female Parkinson disease (PD) patients between 50 and 80 years
- •Subjects who had not received prokinetics (itopride, mosapride, Corydalis tuber, levosulpiride, domperidone, etc.) at least 2 months prior to baseline visit
- •Subjects complained at least one symptom of the following that suggests abnormal bowel functions: anorexia, nausea, abdominal distension, dyspepsia, early satiety, dysphagia, foreign body sensation associated with a meal, symptoms of gastroesophageal reflux, constipation, and defecation problem.
排除标准
- •History of a gastrointestinal operation
- •Subjects with active gastrointestinal diseases under treatment of gastroenterology within 1 month
- •Existence of clinically significant cognitive decline or K-Minimental Status Exam score 20 or less
- •Subjects had depression or other psychiatric disorders treated with medications such as antidepressants or antipsychotics; mood tranquilizers, benzodiazepines, and sleep pills were permitted with fixed dose during a period of the clinical trial
- •Subjects with severe active comorbidities which could interfere the quality of life of the patient
- •Subjects with medical conditions which make difficult to be enrolled to the trial judged by clinicians
- •Subjects with hypersensitivity or adverse event related to DA-9701 (Motilitone)
- •Prior participation to other clinical trials within 3 months
研究组 & 干预措施
Motilitone arm
DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks
干预措施: DA-9701 (Drug)
Placebo arm
DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks
干预措施: DA-9701 (Drug)
Placebo arm
DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks
干预措施: DA-9701 placebo (Drug)
结局指标
主要结局
Change in the Nepean dyspepsia index-Korean version scores
时间窗: 4 weeks
The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms
次要结局
- Change in severity of epigastric pain assessed by a bowel habit questionnaire.(4 weeks, 12 weeks)
- Change in the Patient global improvement (PGI) scores(4 weeks, 12 weeks)
- Change in bowel movements per day assessed by a bowel habit questionnaire.(4 weeks, 12 weeks)
- Change in frequency of early satiety per day assessed by a bowel habit questionnaire.(4 weeks, 12 weeks)
- Change in the Clinician global improvement (CGI) scores(4 weeks, 12 weeks)
- Change in the Bristol stool scale score(4 weeks, 12 weeks)
- Change in the Unified Parkinson's disease rating scale (UPDRS) scores(4 weeks, 12 weeks)
- Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.(4 weeks, 12 weeks)
- Change in the Parkinson's disease quality of life scale (PDQ-39) scores(4 weeks, 12 weeks)
- Change in the Nepean dyspepsia index-Korean version scores(12 weeks)
研究者
Jee-Young Lee
Associate Professor
Seoul National University Hospital