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

August 13, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
        • the Catholic university of korea college of Medicine, Seoul St.Mary's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric fuction of Motilitone
Time Frame: 3 weeks
gastric emptying time on day 4 by scintigraphic imaging
3 weeks
gastric function of Motilitone
Time Frame: 3 weeks
fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events of Motilitone
Time Frame: 3 weeks
3 weeks
small bowel function of Motilitone
Time Frame: 3 weeks
small bowel transit time on day 4 by scintigraphic transit measurement
3 weeks
Colon function of Motilitone
Time Frame: 3 weeks
colon transit time on day 4 and 7 by KUB
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Myung-Gyu Choi, Ph.D., Seul St.Mary's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • DA9701_GA_IV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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