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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03022201 |
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Date of registration:
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23/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease
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Scientific title:
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Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03022201 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Cheol Min Shin, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Bundang Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's
Disease Society Brain Bank criteria
- subjects who are able to explain symptoms they experience and to complete relevant
assessment and exams including questionaires
- subjects who understand the purpose and protocols of the study and agree to
participate on the study
Exclusion Criteria:
- subjects who experience psychiatrical disorders such as cognitive or behavioral
disorders
- subjects who are on prokinetics or who are unable to cease such medication
- subjects who present neurological disorders which influence gastrointestinal mobility
- subjects who present gastrointestinal conditions which influence gastrointestinal
mobility
- subjects with a history of gastrectomy or colectomy
- subjects who are unable to receive and complete the course of medication due to other
metabolic disorders
- subjects diagnosed with parkinson plus syndrome
- subjects who are unable to undergo MRI scan for safety reasons due to claustrophobia
or certain devices such as cardiac pacemakers or aneurysm clips
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease,Idiopathic
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Intervention(s)
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Drug: DA-9701
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Drug: Placebo domperidone
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Drug: Placebo DA-9701
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Drug: Domperidone
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Primary Outcome(s)
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Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
[Time Frame: 0, 4 weeks]
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Secondary Outcome(s)
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UPDRS Part III score
[Time Frame: 0, 4 weeks]
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Patient's symptoms of dyspepsia and constipation assessed patient diary
[Time Frame: -1 to 4 weeks]
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Levodopa plasma concentration 30 minutes after the L-dopa administration
[Time Frame: 0, 4 weeks]
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Secondary ID(s)
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B-1210/173-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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