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A Study to Demonstrate the Efficacy and Safety of Motilitone®

Primary Purpose

Functional Dyspepsia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Motilitone ®

Pantoline®

Motilitone® and Pantoline®

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ajou University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Motilione®

Pantoline®

Motilitone® and Pantoline®

Arm Description

30 mg is administered with a tablet of placebo (Pantoline®)

40mg is administered with a tablet of Motilitone®

Both drugs are administered at once

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Assessment of NDI-K Quality of Life

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

Full Information

NCT ID

NCT01817465

First Posted

March 19, 2013

Last Updated

January 25, 2015

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01817465

Brief Title

A Study to Demonstrate the Efficacy and Safety of Motilitone®

Official Title

A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Dyspepsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

389 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Motilione®

Arm Type

Experimental

Arm Description

30 mg is administered with a tablet of placebo (Pantoline®)

Arm Title

Pantoline®

Arm Type

Active Comparator

Arm Description

40mg is administered with a tablet of Motilitone®

Arm Title

Motilitone® and Pantoline®

Arm Type

Active Comparator

Arm Description

Both drugs are administered at once

Intervention Type

Drug

Intervention Name(s)

Motilitone ®

Intervention Type

Drug

Intervention Name(s)

Pantoline®

Intervention Type

Drug

Intervention Name(s)

Motilitone® and Pantoline®

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Title

Assessment of NDI-K Quality of Life

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: