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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03225248

Enrollment

143

Registered

2017-07-21

Start date

2014-11-05

Completion date

2015-10-12

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

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.

Interventions

DRUGUI05MSP015CT

UI05MSP015CT and Placebo of Gasmotin

DRUGGasmotin

Placebo of UI05MSP015CT and Gasmotin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026