Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Overview

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 Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 5, 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: UI05MSP015CT
    • UI05MSP015CT and Placebo of Gasmotin
  • Active Comparator: Gasmotin
    • Placebo of UI05MSP015CT and Gasmotin

Clinical Trial Outcome Measures

Primary Measures

  • Change of symptom score of functional dyspepsia
    • Time Frame: 4weeks
    • Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea United Pharm. Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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