Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms

Parkinson Disease Clinical Trial

— PASS-GI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775591
• Other study ID #: 26-2016-11
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dyspepsia
• Parkinson Disease

Intervention

Drug:
• DA-9701
DA-9701 30mg Tablet
• DA-9701 placebo
Placebo pill manufactured to mask DA-9701 30mg Tablet

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Veterans Healthcare Service Medical Center	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hanyang University, Korea University Guro Hospital, Samsung Medical Center, Seoul Veterans Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Nepean dyspepsia index-Korean version scores	The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms	4 weeks
Secondary	Change in bowel movements per day assessed by a bowel habit questionnaire.	Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire.	4 weeks, 12 weeks
Secondary	Change in frequency of early satiety per day assessed by a bowel habit questionnaire.	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.	4 weeks, 12 weeks
Secondary	Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.	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.	4 weeks, 12 weeks
Secondary	Change in severity of epigastric pain assessed by a bowel habit questionnaire.	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.	4 weeks, 12 weeks
Secondary	Change in the Bristol stool scale score	This is a descriptive picture plate which patients can choose the type of their stool	4 weeks, 12 weeks
Secondary	Change in the Unified Parkinson's disease rating scale (UPDRS) scores	This is a measure of the severity of Parkinson's disease	4 weeks, 12 weeks
Secondary	Change in the Parkinson's disease quality of life scale (PDQ-39) scores	This is a measure of everyday quality of life affected by Parkinson's disease	4 weeks, 12 weeks
Secondary	Change in the Patient global improvement (PGI) scores	This is a measure of patients perception of change in their gastrointestinal symptoms	4 weeks, 12 weeks
Secondary	Change in the Clinician global improvement (CGI) scores	This is a measure of clinican's assessment of global clinical status of the patient	4 weeks, 12 weeks
Secondary	Change in the Nepean dyspepsia index-Korean version scores	This is a measure of changes in gastrointestinal symptoms at the end of this trial	12 weeks