Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers
NCT ID: NCT01719575
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
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Motilitone
take motilitone 30mg three times daily for the first week After 7 day wash-out period, take placebo three times daily for the second week
Motilitone
Placebo
take placebo three times daily for the first week After 7 day wash-out period, take motilitone 30mg three times daily for the second week
Placebo
Interventions
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Motilitone
Placebo
Eligibility Criteria
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Inclusion Criteria
* no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
* written informed consent
Exclusion Criteria
* history of abdominal surgery that may influence gastrointestinal motility
* gastrointestinal hemorrhage, mechanical ileus, enterobrosis
* irritable bowel syndrome, inflammatory bowel disease
* severe disturbance of liver, kidney, heart,lung,blood and endocrine
* psychoneurosis, alcoholism, drug dependence
* medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks
20 Years
ALL
Yes
Sponsors
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Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Myung-Gyu Choi, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seul St.Mary's hospital
Locations
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the Catholic university of korea college of Medicine, Seoul St.Mary's hospital
Banpo-dong, Seocho-gu, Seoul, South Korea
Countries
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Other Identifiers
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DA9701_GA_IV
Identifier Type: -
Identifier Source: org_study_id