NCT02365701

Study of Motilitone to Treat Functional Dyspepsia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Motilitone 30mg	30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks
DRUG	Placebo	Placebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2015-02-19
• Last updated: 2019-05-21

Locations

1 site across 1 country: United States