Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Phase 3

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: UI05MSP015CT; Drug: Gasmotin

• Registration Number: NCT03225248
• Lead Sponsor: Korea United Pharm. Inc.

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.

Study Timeline

• Study Start: 2014-11-05
• Primary Completion: 2015-09-05
• Study Completion: 2015-10-12
• Status Verified: 2017-07
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UI05MSP015CT	UI05MSP015CT	UI05MSP015CT and Placebo of Gasmotin
Gasmotin	Gasmotin	Placebo of UI05MSP015CT and Gasmotin

Primary Outcome Measures

Name	Time	Method
Change of symptom score of functional dyspepsia	4weeks	Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Secondary Outcome Measures

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