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

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ClinicalTrials.gov Identifier: NCT02775591
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborators:
Samsung Medical Center
Korea University Guro Hospital
Hanyang University
Seoul Veterans Hospital
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jee-Young Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 17, 2016
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
Change in the Nepean dyspepsia index-Korean version scores [ Time Frame: 4 weeks ]
The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2016)
Change in the Nepean dyspepsia index-Korean version scores [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT02775591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Change in bowel movements per day assessed by a bowel habit questionnaire. [ Time Frame: 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. [ Time Frame: 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 frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire. [ Time Frame: 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 severity of epigastric pain assessed by a bowel habit questionnaire. [ Time Frame: 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 Bristol stool scale score [ Time Frame: 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 [ Time Frame: 4 weeks, 12 weeks ]
    This is a measure of the severity of Parkinson's disease
  • Change in the Parkinson's disease quality of life scale (PDQ-39) scores [ Time Frame: 4 weeks, 12 weeks ]
    This is a measure of everyday quality of life affected by Parkinson's disease
  • Change in the Patient global improvement (PGI) scores [ Time Frame: 4 weeks, 12 weeks ]
    This is a measure of patients perception of change in their gastrointestinal symptoms
  • Change in the Clinician global improvement (CGI) scores [ Time Frame: 4 weeks, 12 weeks ]
    This is a measure of clinican's assessment of global clinical status of the patient
  • Change in the Nepean dyspepsia index-Korean version scores [ Time Frame: 12 weeks ]
    This is a measure of changes in gastrointestinal symptoms at the end of this trial
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2016)
  • Change in bowel movements per day assessed by a bowel habit questionnaire. [ Time Frame: 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. [ Time Frame: 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 frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire. [ Time Frame: 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 severity of epigastric pain assessed by a bowel habit questionnaire. [ Time Frame: 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 Bristol stool scale score [ Time Frame: 4 weeks, 12 weeks ]
  • Change in the Unified Parkinson's disease rating scale (UPDRS) scores [ Time Frame: 4 weeks, 12 weeks ]
  • Change in the Parkinson's disease quality of life scale (PDQ-39) scores [ Time Frame: 4 weeks, 12 weeks ]
  • Change in the Patient global improvement (PGI) scores [ Time Frame: 4 weeks, 12 weeks ]
  • Change in the Clinician global improvement (CGI) scores [ Time Frame: 4 weeks, 12 weeks ]
  • Change in the Nepean dyspepsia index-Korean version scores [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Dyspepsia
Intervention  ICMJE
  • Drug: DA-9701
    DA-9701 30mg Tablet
    Other Name: Motilitone
  • Drug: DA-9701 placebo
    Placebo pill manufactured to mask DA-9701 30mg Tablet
    Other Name: Motilitone placebo
Study Arms  ICMJE
  • Experimental: Motilitone arm
    DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks
    Intervention: Drug: DA-9701
  • Placebo Comparator: 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
    Interventions:
    • Drug: DA-9701
    • Drug: DA-9701 placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2019)
147
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2016)
150
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02775591
Other Study ID Numbers  ICMJE 26-2016-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: DATA including IPD can be shared individually upon request by qualified investigators excluding patients' personal information
Time Frame: The information will be judged by the principal investigator upon individual request.
Access Criteria: The information will be judged by the principal investigator upon individual request.
Responsible Party Jee-Young Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Hanyang University
  • Seoul Veterans Hospital
  • SMG-SNU Boramae Medical Center
Investigators  ICMJE
Principal Investigator: Jee-Young Lee, MD, PhD SMG-SNU Boramae Medical Center
PRS Account Seoul National University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP