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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

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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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 5, 2014
Actual Primary Completion Date : September 5, 2015
Actual Study Completion Date : October 12, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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




Primary Outcome Measures :
  1. Change of symptom score of functional dyspepsia [ Time Frame: 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 [ Time Frame: 2weeks ]
    Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

  2. General symptom improvement [ Time Frame: 2weeks, 4weeks ]
    Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.

  3. NDI-K questionnaire [ Time Frame: 4weeks ]
    25 questions on five quality of life areas



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Korea United Pharm. Inc.
ClinicalTrials.gov Identifier: NCT03225248     History of Changes
Other Study ID Numbers: KUP-MSP5-301
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms