Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers
- Registration Number
- NCT01719575
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- no gastrointestinal symptoms
- 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
- pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Motilitone 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 Placebo 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
- Primary Outcome Measures
Name Time Method gastric fuction of Motilitone 3 weeks gastric emptying time on day 4 by scintigraphic imaging
gastric function of Motilitone 3 weeks fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
- Secondary Outcome Measures
Name Time Method adverse events of Motilitone 3 weeks small bowel function of Motilitone 3 weeks small bowel transit time on day 4 by scintigraphic transit measurement
Colon function of Motilitone 3 weeks colon transit time on day 4 and 7 by KUB
Trial Locations
- Locations (1)
the Catholic university of korea college of Medicine, Seoul St.Mary's hospital
🇰🇷Banpo-dong, Seocho-gu, Seoul, Korea, Republic of