Skip to main content
OpenTrials
Completed

NCT Number: NCT03225248

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Dyspepsia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >19 years
  • Diagnosis of functional dyspepsia meeting Rome III criteria
  • At least three moderate or severe symptoms included in the Symptom Score
  • No structural lesions of upper gastrointestinal tract

Exclusion criteria

  • History of dyspepsia unrelated to functional dyspepsia or diseases
  • History of gastrointestinal surgery
  • History of malignancy in the previous 5 years
  • Psychiatric disorders including major depressive disorder and anxiety
  • Liver cirrhosis or abnormal liver laboratory findings
  • Advanced chronic kidney disease
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Pregnancy and lactation
  • Recent history of taking medication affecting the gastrointestinal system

Treatment and study plan

UI05MSP015CT

Drug

UI05MSP015CT and Placebo of Gasmotin

Gasmotin

Drug

Placebo of UI05MSP015CT and Gasmotin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea United Pharm. Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2017
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.