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Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers (DA-9701)

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ClinicalTrials.gov Identifier: NCT01719575
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( 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.

Condition or disease Intervention/treatment Phase
Healthy Female and Male Drug: Motilitone Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers
Study Start Date : March 2012
Actual Primary Completion Date : November 2012

Arm Intervention/treatment
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
Drug: 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
Drug: Placebo



Primary Outcome Measures :
  1. gastric fuction of Motilitone [ Time Frame: 3 weeks ]
    gastric emptying time on day 4 by scintigraphic imaging

  2. gastric function of Motilitone [ Time Frame: 3 weeks ]
    fasting and postprandial gastric volume on day 7 by single photon emission computed tomography


Secondary Outcome Measures :
  1. adverse events of Motilitone [ Time Frame: 3 weeks ]
  2. small bowel function of Motilitone [ Time Frame: 3 weeks ]
    small bowel transit time on day 4 by scintigraphic transit measurement

  3. Colon function of Motilitone [ Time Frame: 3 weeks ]
    colon transit time on day 4 and 7 by KUB



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719575


Locations
Korea, Republic of
the Catholic university of korea college of Medicine, Seoul St.Mary's hospital
Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Myung-Gyu Choi, Ph.D. Seul St.Mary's hospital

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01719575     History of Changes
Other Study ID Numbers: DA9701_GA_IV
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013