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Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers

This study is currently recruiting participants.
Verified August 2012 by The Catholic University of Korea
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Myung-gui Choi, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01669772
First received: August 12, 2012
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
 Drug: DA-9701 and placebo
Drug: Placebo and DA-9701
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Study the effects of DA-9701 on GI motility in healthy adult volunteers [ Time Frame: 3weeks ] [ Designated as safety issue: Yes ]
    Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers


Secondary Outcome Measures:
  • Examine the effects of DA-9701 by Scintigraphic transit measurement [ Time Frame: 3weeks ] [ Designated as safety issue: No ]
    Examine the effects of DA-9701 by Scintigraphic transit measurement

  • Examine the effects of DA-9701 by EGG/Drink test [ Time Frame: 3weeks ] [ Designated as safety issue: No ]
    Examine the effects of DA-9701 by EGG/Drink test

  • Examine the effects of DA-9701 by SPECT [ Time Frame: 3weeks ] [ Designated as safety issue: No ]
    Examine the effects of DA-9701 by SPECT


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DA-9701 and placebo
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.
 Drug: DA-9701 and placebo
Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.
Other Name: DA-9701(motilitone)
Placebo and DA-9701
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.
 Drug: Placebo and DA-9701
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.
Other Name: DA-9701(motilitone)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults of either sex, at least 20 years of age
  • Having no abdominal discomfort or pain
  • No diseases diagnosed by screening gastroduodenoscopy
  • Having given voluntary written consent

Exclusion Criteria:

  • Currently participating or having participated in another drug trial within four weeks of trial start.
  • Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
  • A history of surgery which may affect gastrointestinal motility.
  • Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
  • Subjects with irritable bowel syndrome or inflammatory bowel disease.
  • Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system.
  • Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.
  • Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks.
  • Other reasons that the investigator considers valid.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669772

Locations
Korea, Republic of
Seoul St Mary's hospital Recruiting
Seoul, Korea, Republic of
Contact: Myong-Ki Baeg, MD         biosoul@hanmail.net    
Sponsors and Collaborators
Myung-gui Choi
Dong-A Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Myung-gui Choi, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01669772     History of Changes
Other Study ID Numbers: DA-9701 trial
Study First Received: August 12, 2012
Last Updated: August 17, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013