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

Not Applicable

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Placebo (for Motilitone); Drug: Motilitone

• Registration Number: NCT02091635
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• Patients were excluded if they met any of the following criteria:

  1. any functional GI disease or previous abdominal surgery
  2. diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment
  3. significant cardiopulmonary diseases or any malignancies
  4. 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
  5. taking medications that may alter gastric function within 2 weeks prior to the start of the study
  6. pregnancy or lactation
  7. females with inadequate contraception during the study period
  8. contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip)
  9. allergic history to motilitone
  10. other conditions likely to interfere with study procedures, as judged by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motilitone	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).
Placebo (for Motilitone)	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of