Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

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)

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: UI05MSP015CT; Drug: Gasmotin

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UI05MSP015CT; UI05MSP015CT and Placebo of Gasmotin	Drug: UI05MSP015CT; UI05MSP015CT and Placebo of Gasmotin
Active Comparator: Gasmotin; Placebo of UI05MSP015CT and Gasmotin	Drug: Gasmotin; Placebo of UI05MSP015CT and Gasmotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of symptom score of functional dyspepsia	Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.	4weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of symptom score of functional dyspepsia	Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.	2weeks
General symptom improvement	Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.	2weeks, 4weeks
NDI-K questionnaire	25 questions on five quality of life areas	4weeks

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2014
• Primary Completion (Actual): September 5, 2015
• Study Completion (Actual): October 12, 2015

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: KUP-MSP5-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No