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

Primary Purpose

Parkinson Disease, Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-9701
DA-9701 placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanyang University Medical Center
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul National University Boramae Hospital
  • Veterans Healthcare Service Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Motilitone arm

Placebo arm

Arm Description

DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks

DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks

Outcomes

Primary Outcome Measures

Change in the Nepean dyspepsia index-Korean version scores
The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms

Secondary Outcome Measures

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.
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.
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.
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.
Change in the Bristol stool scale score
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
This is a measure of the severity of Parkinson's disease
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
Change in the Patient global improvement (PGI) scores
This is a measure of patients perception of change in their gastrointestinal symptoms
Change in the Clinician global improvement (CGI) scores
This is a measure of clinican's assessment of global clinical status of the patient
Change in the Nepean dyspepsia index-Korean version scores
This is a measure of changes in gastrointestinal symptoms at the end of this trial

Full Information

First Posted
May 9, 2016
Last Updated
March 26, 2019
Sponsor
Seoul National University Hospital
Collaborators
Samsung Medical Center, Korea University Guro Hospital, Hanyang University, Seoul Veterans Hospital, SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02775591
Brief Title
Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samsung Medical Center, Korea University Guro Hospital, Hanyang University, Seoul Veterans Hospital, SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motilitone arm
Arm Type
Experimental
Arm Description
DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DA-9701
Other Intervention Name(s)
Motilitone
Intervention Description
DA-9701 30mg Tablet
Intervention Type
Drug
Intervention Name(s)
DA-9701 placebo
Other Intervention Name(s)
Motilitone placebo
Intervention Description
Placebo pill manufactured to mask DA-9701 30mg Tablet
Primary Outcome Measure Information:
Title
Change in the Nepean dyspepsia index-Korean version scores
Description
The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in bowel movements per day assessed by a bowel habit questionnaire.
Description
Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire.
Time Frame
4 weeks, 12 weeks
Title
Change in frequency of early satiety per day assessed by a bowel habit questionnaire.
Description
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.
Time Frame
4 weeks, 12 weeks
Title
Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.
Description
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.
Time Frame
4 weeks, 12 weeks
Title
Change in severity of epigastric pain assessed by a bowel habit questionnaire.
Description
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.
Time Frame
4 weeks, 12 weeks
Title
Change in the Bristol stool scale score
Description
This is a descriptive picture plate which patients can choose the type of their stool
Time Frame
4 weeks, 12 weeks
Title
Change in the Unified Parkinson's disease rating scale (UPDRS) scores
Description
This is a measure of the severity of Parkinson's disease
Time Frame
4 weeks, 12 weeks
Title
Change in the Parkinson's disease quality of life scale (PDQ-39) scores
Description
This is a measure of everyday quality of life affected by Parkinson's disease
Time Frame
4 weeks, 12 weeks
Title
Change in the Patient global improvement (PGI) scores
Description
This is a measure of patients perception of change in their gastrointestinal symptoms
Time Frame
4 weeks, 12 weeks
Title
Change in the Clinician global improvement (CGI) scores
Description
This is a measure of clinican's assessment of global clinical status of the patient
Time Frame
4 weeks, 12 weeks
Title
Change in the Nepean dyspepsia index-Korean version scores
Description
This is a measure of changes in gastrointestinal symptoms at the end of this trial
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee-Young Lee, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Veterans Healthcare Service Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
DATA including IPD can be shared individually upon request by qualified investigators excluding patients' personal information
IPD Sharing Time Frame
The information will be judged by the principal investigator upon individual request.
IPD Sharing Access Criteria
The information will be judged by the principal investigator upon individual request.
Citations:
PubMed Identifier
32761955
Citation
Choi JH, Lee JY, Cho JW, Koh SB, Yang YS, Yoo D, Shin CM, Kim HT. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study. Mov Disord. 2020 Nov;35(11):1966-1976. doi: 10.1002/mds.28219. Epub 2020 Aug 6.
Results Reference
derived

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

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