<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/NCT01669772</url>
  </required_header>
  <id_info>
    <org_study_id>DA-9701 trial</org_study_id>
    <nct_id>NCT01669772</nct_id>
  </id_info>
  <brief_title>Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers</brief_title>
  <official_title>Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Myung-gui Choi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dong-A Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These&#xD;
      plants have been used in oriental traditional medicine for the treatment of gastrointestinal&#xD;
      maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in&#xD;
      functional dyspepsia patients and proved to have comparable safety and efficacy. However,&#xD;
      its' exact effect on the gastrointestinal motility has not been completely elucidated. This&#xD;
      study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study the effects of DA-9701 on GI motility in healthy adult volunteers</measure>
    <time_frame>3weeks</time_frame>
    <description>Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine the effects of DA-9701 by Scintigraphic transit measurement</measure>
    <time_frame>3weeks</time_frame>
    <description>Examine the effects of DA-9701 by Scintigraphic transit measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examine the effects of DA-9701 by EGG/Drink test</measure>
    <time_frame>3weeks</time_frame>
    <description>Examine the effects of DA-9701 by EGG/Drink test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examine the effects of DA-9701 by SPECT</measure>
    <time_frame>3weeks</time_frame>
    <description>Examine the effects of DA-9701 by SPECT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>DA-9701 and placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Administer DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and DA-9701</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-9701 and placebo</intervention_name>
    <description>Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.</description>
    <arm_group_label>DA-9701 and placebo</arm_group_label>
    <other_name>DA-9701(motilitone)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo and DA-9701</intervention_name>
    <description>Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week.</description>
    <arm_group_label>Placebo and DA-9701</arm_group_label>
    <other_name>DA-9701(motilitone)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults of either sex, at least 20 years of age&#xD;
&#xD;
          -  Having no abdominal discomfort or pain&#xD;
&#xD;
          -  No diseases diagnosed by screening gastroduodenoscopy&#xD;
&#xD;
          -  Having given voluntary written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating or having participated in another drug trial within four weeks&#xD;
             of trial start.&#xD;
&#xD;
          -  Women of childbearing age who are either pregnant, breast-feeding or not under proper&#xD;
             contraceptive methods.&#xD;
&#xD;
          -  A history of surgery which may affect gastrointestinal motility.&#xD;
&#xD;
          -  Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.&#xD;
&#xD;
          -  Subjects with irritable bowel syndrome or inflammatory bowel disease.&#xD;
&#xD;
          -  Subjects with serious conditions involving the liver, kidneys, heart, lung or&#xD;
             endocrinology system.&#xD;
&#xD;
          -  Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.&#xD;
&#xD;
          -  Subjects who have taken drugs that may affect the study outcome such as antibiotics,&#xD;
             corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers,&#xD;
             proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2&#xD;
             weeks.&#xD;
&#xD;
          -  Other reasons that the investigator considers valid.&#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>Myong Ki Baeg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CU Korea, Seoul St Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Myung-gui Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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/NCT01669772
org study id: DA-9701 trial
nct id: NCT01669772
lead sponsor: 
collaborator: 
has dmc: Yes
DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These
      plants have been used in oriental traditional medicine for the treatment of gastrointestinal
      maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in
      functional dyspepsia patients and proved to have comparable safety and efficacy. However,
      its' exact effect on the gastrointestinal motility has not been completely elucidated. This
      study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Study the effects of DA-9701 on GI motility in healthy adult volunteers
time frame: 3weeks
description: Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers
measure: Examine the effects of DA-9701 by Scintigraphic transit measurement
time frame: 3weeks
description: Examine the effects of DA-9701 by Scintigraphic transit measurement
measure: Examine the effects of DA-9701 by EGG/Drink test
time frame: 3weeks
description: Examine the effects of DA-9701 by EGG/Drink test
measure: Examine the effects of DA-9701 by SPECT
time frame: 3weeks
description: Examine the effects of DA-9701 by SPECT
arm group label: DA-9701 and placebo
arm group type: Other
description: Administer DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again.
arm group label: Placebo and DA-9701
arm group type: Other
description: Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again.
intervention type: Drug
intervention name: DA-9701 and placebo
description: Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.
arm group label: DA-9701 and placebo
other name: DA-9701(motilitone)
intervention type: Drug
intervention name: Placebo and DA-9701
description: Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week.
arm group label: Placebo and DA-9701
other name: DA-9701(motilitone)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Myong Ki Baeg, MD
role: Principal Investigator
affiliation: CU Korea, Seoul St Mary's Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Myung-gui Choi
investigator title: Professor