MedTrace Logo

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

NCT01669772 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-07-03

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

DA-9701 and placebo

Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.

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.

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Myung-gui Choi

    lead OTHER

Principal Investigators

  • Myong Ki Baeg, MD · CU Korea, Seoul St Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-02-28
Completion
2013-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01669772 on ClinicalTrials.gov