Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Korea United Pharm

Status and phase: Completed; Phase 3

Conditions: Functional Dyspepsia

Treatments: Drug: UI05MSP015CT; Drug: Gasmotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03225248

KUP-MSP5-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups

UI05MSP015CT

Experimental group

Description:

UI05MSP015CT and Placebo of Gasmotin

Treatment:

Drug: UI05MSP015CT

Gasmotin

Active Comparator group

Description:

Placebo of UI05MSP015CT and Gasmotin

Treatment:

Drug: Gasmotin