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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225248
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Korea United Pharm. Inc.

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE November 5, 2014
Actual Primary Completion Date September 5, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
Change of symptom score of functional dyspepsia [ Time Frame: 4weeks ]
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE
  • Drug: UI05MSP015CT
    UI05MSP015CT and Placebo of Gasmotin
  • Drug: Gasmotin
    Placebo of UI05MSP015CT and Gasmotin
Study Arms  ICMJE
  • Experimental: UI05MSP015CT
    UI05MSP015CT and Placebo of Gasmotin
    Intervention: Drug: UI05MSP015CT
  • Active Comparator: Gasmotin
    Placebo of UI05MSP015CT and Gasmotin
    Intervention: Drug: Gasmotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2017)
143
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 12, 2015
Actual Primary Completion Date September 5, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03225248
Other Study ID Numbers  ICMJE KUP-MSP5-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Korea United Pharm. Inc.
Study Sponsor  ICMJE Korea United Pharm. Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Korea United Pharm. Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP