NCT01669772

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

August 12, 2012

Last Update Submit

July 2, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Examine the effects of DA-9701 by Scintigraphic transit measurement

    3weeks

  • Examine the effects of DA-9701 by EGG/Drink test

    3weeks

  • Examine the effects of DA-9701 by SPECT

    3weeks

Study Arms (2)

DA-9701 and placebo

OTHER

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

Placebo and DA-9701

OTHER

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

Interventions

DA-9701 and placeboDRUG

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

Also known as: DA-9701(motilitone)
DA-9701 and placebo
Placebo and DA-9701DRUG

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.

Also known as: DA-9701(motilitone)
Placebo and DA-9701

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

DA-9701

Study Officials

  • Myong Ki Baeg, MD

    CU Korea, Seoul St Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 21, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2013

Study Completion

December 1, 2013

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

KR(1)