Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

• Sponsor: Korea United Pharm. Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03225248
• Collaborator: (none)
• Enrollment: 143
• Arms: 2
• Actual Duration (Months): 11.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia	Drug: UI05MSP015CT; Drug: Gasmotin	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Nov 5, 2014
• Actual Primary Completion Date: Sep 5, 2015
• Actual Study Completion Date: Oct 12, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UI05MSP015CT UI05MSP015CT and Placebo of Gasmotin	Drug: UI05MSP015CT; UI05MSP015CT and Placebo of Gasmotin
Active Comparator: Gasmotin Placebo of UI05MSP015CT and Gasmotin	Drug: Gasmotin; Placebo of UI05MSP015CT and Gasmotin

Outcome Measures

Primary Outcome Measures

1. Change of symptom score of functional dyspepsia [4weeks]

   Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Secondary Outcome Measures

1. Change of symptom score of functional dyspepsia [2weeks]

   Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

2. General symptom improvement [2weeks, 4weeks]

   Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.

3. NDI-K questionnaire [4weeks]

   25 questions on five quality of life areas

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Korea United Pharm. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Korea United Pharm. Inc.
• ClinicalTrials.gov Identifier: NCT03225248
• Other Study ID Numbers: KUP-MSP5-301
• First Posted: Jul 21, 2017
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyspepsia

Study Results

No Results Posted as of Jul 21, 2017