Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers

A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01719575

Acronym

DA-9701

Enrollment

Registered

2012-11-01

Start date

2012-03-31

Completion date

Unknown

Last updated

2013-08-15

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

Conditions

Healthy Female and Male

Brief summary

The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.

Interventions

DRUGMotilitone

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* no gastrointestinal symptoms * no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy * written informed consent

Exclusion criteria

* pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception * history of abdominal surgery that may influence gastrointestinal motility * gastrointestinal hemorrhage, mechanical ileus, enterobrosis * irritable bowel syndrome, inflammatory bowel disease * severe disturbance of liver, kidney, heart,lung,blood and endocrine * psychoneurosis, alcoholism, drug dependence * medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks

Design outcomes

Primary

Measure	Time frame	Description
gastric fuction of Motilitone	3 weeks	gastric emptying time on day 4 by scintigraphic imaging
gastric function of Motilitone	3 weeks	fasting and postprandial gastric volume on day 7 by single photon emission computed tomography

Secondary

Measure	Time frame	Description
adverse events of Motilitone	3 weeks	—
small bowel function of Motilitone	3 weeks	small bowel transit time on day 4 by scintigraphic transit measurement
Colon function of Motilitone	3 weeks	colon transit time on day 4 and 7 by KUB

Countries

South Korea

Outcome results

None listed

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