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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

UI05MSP015CT

Gasmotin

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

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

Inclusion Criteria:

Age >19 years
Diagnosis of functional dyspepsia meeting Rome III criteria
At least three moderate or severe symptoms included in the Symptom Score
No structural lesions of upper gastrointestinal tract

Exclusion Criteria:

History of dyspepsia unrelated to functional dyspepsia or diseases
History of gastrointestinal surgery
History of malignancy in the previous 5 years
Psychiatric disorders including major depressive disorder and anxiety
Liver cirrhosis or abnormal liver laboratory findings
Advanced chronic kidney disease
Uncontrolled hypertension
Uncontrolled diabetes
Pregnancy and lactation
Recent history of taking medication affecting the gastrointestinal system

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UI05MSP015CT

Gasmotin

Arm Description

UI05MSP015CT and Placebo of Gasmotin

Placebo of UI05MSP015CT and Gasmotin

Outcomes

Primary Outcome Measures

Change of symptom score of functional dyspepsia

Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Secondary Outcome Measures

Change of symptom score of functional dyspepsia

Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

General symptom improvement

Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.

NDI-K questionnaire

25 questions on five quality of life areas

Full Information

NCT ID

NCT03225248

First Posted

July 12, 2017

Last Updated

July 20, 2017

Sponsor

Korea United Pharm. Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03225248

Brief Title

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Official Title

Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 5, 2014 (Actual)

Primary Completion Date

September 5, 2015 (Actual)

Study Completion Date

October 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Korea United Pharm. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Detailed Description

Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UI05MSP015CT

Arm Type

Experimental

Arm Description

UI05MSP015CT and Placebo of Gasmotin

Arm Title

Gasmotin

Arm Type

Active Comparator

Arm Description

Placebo of UI05MSP015CT and Gasmotin

Intervention Type

Drug

Intervention Name(s)

UI05MSP015CT

Intervention Description

UI05MSP015CT and Placebo of Gasmotin

Intervention Type

Drug

Intervention Name(s)

Gasmotin

Intervention Description

Placebo of UI05MSP015CT and Gasmotin

Primary Outcome Measure Information:

Title

Change of symptom score of functional dyspepsia

Description

Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Time Frame

4weeks

Secondary Outcome Measure Information:

Title

Change of symptom score of functional dyspepsia

Description

Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Time Frame

2weeks

Title

General symptom improvement

Description

Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.

Time Frame

2weeks, 4weeks

Title

NDI-K questionnaire

Description

25 questions on five quality of life areas

Time Frame

4weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >19 years Diagnosis of functional dyspepsia meeting Rome III criteria At least three moderate or severe symptoms included in the Symptom Score No structural lesions of upper gastrointestinal tract Exclusion Criteria: History of dyspepsia unrelated to functional dyspepsia or diseases History of gastrointestinal surgery History of malignancy in the previous 5 years Psychiatric disorders including major depressive disorder and anxiety Liver cirrhosis or abnormal liver laboratory findings Advanced chronic kidney disease Uncontrolled hypertension Uncontrolled diabetes Pregnancy and lactation Recent history of taking medication affecting the gastrointestinal system

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

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