Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers (DA-9701)

Dong-A Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Healthy Female and Male

Treatments

Drug: Motilitone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01719575

DA9701_GA_IV

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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