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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Placebo (for Motilitone)
* Drug: Motilitone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers between 20 and 70 years of age without upper abdominal pain or discomfort and a structural abnormality on upper gastrointestinal (GI) endoscopy performed within the preceding 6 months were eligible for the trial. Exclusion Criteria: Patients were excluded if they met any of the following criteria: any functional GI disease or previous abdominal surgery diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment significant cardiopulmonary diseases or any malignancies significant renal (serum creatinine level ≥ 1.5 × the upper normal limit) or liver disease (serum aspartate aminotransferase and alanine aminotransferase levels ≥ 2.5 × the upper normal limits taking medications that may alter gastric function within 2 weeks prior to the start of the study pregnancy or lactation females with inadequate contraception during the study period contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip) allergic history to motilitone other conditions likely to interfere with study procedures, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motilitone<br>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: Placebo (for Motilitone)<br>* 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).<br>* Other names: Sugar pill manufactured to mimic Motilitone 60mg tablet;|
| Placebo Comparator: Placebo (for Motilitone)<br>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<br>* 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).<br>* Other names: DA-9701;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total gastric volume (TGV) after the test meal |  | This outcome is measured on day 7 after 5days of treatment. The change is defined as difference between TGV 15min after the test meal and at the pre-test meal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying (GE) rate |  | This outcome is measured on day 7 after 5 days of treatment | 
| Change in proximal TGV after the test meal |  | This outcome is mesured on day 7 after 5 days of treatment. The change is defined as difference between proximal TGV 15 min after the test meal and at the pre-test meal. | 
| Change in proximal to distal TGV ratio after the test meal |  | This outcome is measured on day 7 after 5 days of treatment. The change is defined as difference between proximal to distal TGV ratio 15 min after the test meal and at the pre-test meal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accommodation, emptying, motilitone