Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia: Evaluation Using MRI Method

Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia:

Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause.1 Several mechanisms have been suggested to underlie dyspeptic symptoms. In a barostat study by Tack et al.2, impaired gastric accommodation to a meal was found in 40% of patients with FD, and this abnormality was associated with early satiety. Delayed gastric emptying (GE) was also found in almost 40% of patients with FD, and was associated with the symptoms of postprandial fullness, vomiting and early satiety.3-5 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. It has multiple mechanisms of action such as fundus relaxation, visceral analgesia and prokinetic effects.6 The current study aims to evaluate effects of motilitone on gastric emptying and accommodation after a meal in patients with FD using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Patients are randomly allocated to receive either motilitone 90 mg daily, motilitone 180 mg daily or placebo in a double blinded manner. After 2 weeks of treatment, patients undergo gastric MRI. The primary endpoint is gastric emptying rate. The secondary endpoints are gastric accommodation and symptom improvement.

Study Overview

• Status: Unknown
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: motilitone; Drug: Placebo

Detailed Description

Same as above

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Department of Medicine, Samsung Medical Center,Sungkyunkwan University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 20 and 70 years of age
2. Diagnosed of functional dyspepsia patients by ROME III diagnostic criteria
3. Symptom scores three-point by 8 kinds of symptoms on NDI-K table
4. Signed written informed consent.

Exclusion Criteria:

1. Any functional GI diease
2. Previous abdominal surgery
3. pregnancy or lactation
4. Other conditions likely to interfere with study procedures. as judged by the investigator
5. Allergic history to motilitone
6. Contraindications to MRI
7. Significant cardiopulmonary disease
8. Significant renal(serum creatinine level≥1.5 x the upper normal limit) or liver (AST or ALT≥2.5xULN)disease
9. Can not be stopped taking medications that gastric motility booster and antacid prior to the start of the study
10. Uncontrollable diabetes mellitus (HbA1C>7%)
11. Any malignancies within 5 years prior to the start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: motilitone 90mg; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.	Drug: motilitone; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
Active Comparator: motilitone 180mg; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.	Drug: motilitone; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
Placebo Comparator: placebo; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.	Drug: Placebo; Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation in gastric emptying rate after the test meal	Evaluation in gastric emptying rate 120min after the test meal

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary endpoints are gastric accommodation and symptom improvement.	This outcome is measured on day 14 after 2 weeks of treatment
Change in total gastric volume (TGV) after the test meal	This outcome is measured on day 14 after 2 weeks of treatment.The change is defined as difference between TGV 15min after the test meal and at the pre-test meal.
Gastric emptying rate(GE)	GE 15min 30min 60min after the test meal.
Change in proximal total gastric volume (TGV) after the test meal	The chanfe is defined as difference between proximal TGV 15min after the test meal
Change in proximal to distal total gastric volume (TGV) ratio afrer the test meal	The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Poong-Lyul Rhee, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: accommodation, emptying,motilitone
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2013-12-026