Clinical Trial: Study of Motilitone to Treat Functional Dyspepsia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Double-blind, Placebo-controlled, Randomized, 4-week, Phase II Clinical Trial for Assessment of Efficacy and Safety of Motilitone in Patients With Functional Dyspepsia

Brief Summary: This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in patients with Functional Dyspepsia as measured by change in maximum tolerated volume and aggregate symptom score on the nutrient drink test.

Detailed Summary:
Sponsor: Dong-A ST Co., Ltd.

Current Primary Outcome:

  • Change in maximum tolerated volume by nutrient drink test [ Time Frame: week -2, week 4 ]
  • Change in aggregate symptom score by nutrient drink test [ Time Frame: week -2, week 4 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Dong-A ST Co., Ltd.

Dates:
Date Received: September 5, 2014
Date Started: March 2015
Date Completion: December 2017
Last Updated: August 15, 2016
Last Verified: August 2016