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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669772

Enrollment

Registered

2012-08-21

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2014-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGDA-9701 and placebo

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

DRUGPlacebo 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026