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Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method

NCT02091635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-03-19

No results posted yet for this study

Summary

Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause. Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. The current study aims to evaluate effects of motilitone on gastric accommodation and emptying after a meal in a group of healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI. The primary endpoint is gastric accommodation.

Conditions

  • Dyspepsia

Interventions

DRUG

Placebo (for Motilitone)

Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).

DRUG

Motilitone

Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091635 on ClinicalTrials.gov