A Study to Demonstrate the Efficacy and Safety of Motilitone®

Dong-A ST Co., Ltd.389 enrolled

Overview

This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

389

Conditions

Functional Dyspepsia

Interventions

Motilitone ®DRUG

Pantoline®DRUG

Motilitone® and Pantoline®DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Roman III criteria * One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness * No organic lesion Exclusion Criteria: * has been administered or was administered within a month * had a surgery that might affect gastrointestinal motility * Tegaserod

Locations (1)

Ajou University Medical Center

Suwon, South Korea

Outcomes

Primary Outcomes

Subject global assessment by using 5-Likert scale and Binary outcome methods

5-Likert scale: 0: worse 1. similar 2. improved in some degree 3. considerably improved 4. completely cured Binary outcome: yes/no

Time frame: 6 weeks

Secondary Outcomes

Number of dyspepsia(indigestion) symptoms occurred (Counted daily)

Time frame: 6 weeks

Assessment of NDI-K Quality of Life

Time frame: 6 weeks

Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5

Time frame: 6 weeks

Data from ClinicalTrials.gov

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