Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225248
• Other study ID #: KUP-MSP5-301
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2017
• Last updated: July 20, 2017
• Start date: November 5, 2014
• Est. completion date: October 12, 2015

Study information

• Verified date: July 2017
• Source: Korea United Pharm. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 12, 2015
• Est. primary completion date: September 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• UI05MSP015CT
UI05MSP015CT and Placebo of Gasmotin
• Gasmotin
Placebo of UI05MSP015CT and Gasmotin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea United Pharm. Inc.

Outcome

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