Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms
- Registration Number
- NCT02775591
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm DA-9701 placebo DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks Motilitone arm DA-9701 DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks Placebo arm DA-9701 DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks
- Primary Outcome Measures
Name Time Method Change in the Nepean dyspepsia index-Korean version scores 4 weeks The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms
- Secondary Outcome Measures
Name Time Method Change in severity of epigastric pain assessed by a bowel habit questionnaire. 4 weeks, 12 weeks Existence and severity of epigastric pain of recent 1 week will be asked using the bowel habit questionnaire. The severity will be categorized as following: 0, no event; 1, mild; 2, moderate; 3, severe; 4, very severe.
Change in the Patient global improvement (PGI) scores 4 weeks, 12 weeks This is a measure of patients perception of change in their gastrointestinal symptoms
Change in bowel movements per day assessed by a bowel habit questionnaire. 4 weeks, 12 weeks Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire.
Change in frequency of early satiety per day assessed by a bowel habit questionnaire. 4 weeks, 12 weeks Mean frequency of early satiety per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal.
Change in the Clinician global improvement (CGI) scores 4 weeks, 12 weeks This is a measure of clinican's assessment of global clinical status of the patient
Change in the Bristol stool scale score 4 weeks, 12 weeks This is a descriptive picture plate which patients can choose the type of their stool
Change in the Unified Parkinson's disease rating scale (UPDRS) scores 4 weeks, 12 weeks This is a measure of the severity of Parkinson's disease
Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire. 4 weeks, 12 weeks Mean frequency of gastric fullness after a meal per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal.
Change in the Parkinson's disease quality of life scale (PDQ-39) scores 4 weeks, 12 weeks This is a measure of everyday quality of life affected by Parkinson's disease
Change in the Nepean dyspepsia index-Korean version scores 12 weeks This is a measure of changes in gastrointestinal symptoms at the end of this trial
Trial Locations
- Locations (5)
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Veterans Healthcare Service Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Hospital
🇰🇷Seoul, Korea, Republic of