<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719575</url>
  </required_header>
  <id_info>
    <org_study_id>DA9701_GA_IV</org_study_id>
    <nct_id>NCT01719575</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers</brief_title>
  <acronym>DA-9701</acronym>
  <official_title>A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of Motilitone and placebo on gastric&#xD;
      volumes, gastric emptying, small bowel transit and colon transit in female and male healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gastric fuction of Motilitone</measure>
    <time_frame>3 weeks</time_frame>
    <description>gastric emptying time on day 4 by scintigraphic imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gastric function of Motilitone</measure>
    <time_frame>3 weeks</time_frame>
    <description>fasting and postprandial gastric volume on day 7 by single photon emission computed tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events of Motilitone</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>small bowel function of Motilitone</measure>
    <time_frame>3 weeks</time_frame>
    <description>small bowel transit time on day 4 by scintigraphic transit measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colon function of Motilitone</measure>
    <time_frame>3 weeks</time_frame>
    <description>colon transit time on day 4 and 7 by KUB</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Female and Male</condition>
  <arm_group>
    <arm_group_label>Motilitone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Motilitone</intervention_name>
    <arm_group_label>Motilitone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no gastrointestinal symptoms&#xD;
&#xD;
          -  no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux&#xD;
             esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having&#xD;
             normal upper abdominal endoscopy&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant, breast-feeding female,those of childbearing age who were not using an&#xD;
             approved method of contraception&#xD;
&#xD;
          -  history of abdominal surgery that may influence gastrointestinal motility&#xD;
&#xD;
          -  gastrointestinal hemorrhage, mechanical ileus, enterobrosis&#xD;
&#xD;
          -  irritable bowel syndrome, inflammatory bowel disease&#xD;
&#xD;
          -  severe disturbance of liver, kidney, heart,lung,blood and endocrine&#xD;
&#xD;
          -  psychoneurosis, alcoholism, drug dependence&#xD;
&#xD;
          -  medications that may alter evaluation of Motilitone including&#xD;
             antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI,&#xD;
             anticolines, erythromycin, antidepressive agents withing 2weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myung-Gyu Choi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seul St.Mary's hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the Catholic university of korea college of Medicine, Seoul St.Mary's hospital</name>
      <address>
        <city>Banpo-dong, Seocho-gu</city>
        <state>Seoul</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>August 13, 2013</last_update_submitted>
  <last_update_submitted_qc>August 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719575
org study id: DA9701_GA_IV
nct id: NCT01719575
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: gastric fuction of Motilitone
time frame: 3 weeks
description: gastric emptying time on day 4 by scintigraphic imaging
measure: gastric function of Motilitone
time frame: 3 weeks
description: fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
measure: adverse events of Motilitone
time frame: 3 weeks
measure: small bowel function of Motilitone
time frame: 3 weeks
description: small bowel transit time on day 4 by scintigraphic transit measurement
measure: Colon function of Motilitone
time frame: 3 weeks
description: colon transit time on day 4 and 7 by KUB
arm group label: Motilitone
arm group type: Other
description: 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
arm group label: Placebo
arm group type: Other
description: 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
intervention type: Drug
intervention name: Motilitone
arm group label: Motilitone
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Myung-Gyu Choi, Ph.D.
role: Principal Investigator
affiliation: Seul St.Mary's hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor