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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01719575
First received: October 26, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Healthy Female and Male
Drug: Motilitone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers

Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • gastric fuction of Motilitone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    gastric emptying time on day 4 by scintigraphic imaging

  • gastric function of Motilitone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    fasting and postprandial gastric volume on day 7 by single photon emission computed tomography


Secondary Outcome Measures:
  • adverse events of Motilitone [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • small bowel function of Motilitone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    small bowel transit time on day 4 by scintigraphic transit measurement

  • Colon function of Motilitone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    colon transit time on day 4 and 7 by KUB


Enrollment: 30
Study Start Date: March 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ST Co., Ltd.
Investigators
Principal Investigator: Myung-Gyu Choi, Ph.D. Seul St.Mary's hospital
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01719575     History of Changes
Other Study ID Numbers: DA9701_GA_IV
Study First Received: October 26, 2012
Last Updated: August 13, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014