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

Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: DA-9701 and placebo; Drug: Placebo and DA-9701

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St Mary's Hospital

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: DA-9701(motilitone)
Other: 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 Names: DA-9701(motilitone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the effects of DA-9701 on GI motility in healthy adult volunteers	Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers	3weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the effects of DA-9701 by Scintigraphic transit measurement	Examine the effects of DA-9701 by Scintigraphic transit measurement	3weeks
Examine the effects of DA-9701 by EGG/Drink test	Examine the effects of DA-9701 by EGG/Drink test	3weeks
Examine the effects of DA-9701 by SPECT	Examine the effects of DA-9701 by SPECT	3weeks

Collaborators and Investigators

• Sponsor: Myung-gui Choi
• Collaborators: Dong-A Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Myong Ki Baeg, MD, CU Korea, Seoul St Mary's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 12, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: DA-9701 trial