Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

• Status: Completed
• Trial end date: 2015-10-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea United Pharm. Inc.

Criteria

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