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

NCT ID: NCT02151708

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-02-28

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.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.

Detailed Description

Same as above

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

motilitone

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

motilitone

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Poong-Lyul Rhee

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Poong-Lyul Rhee, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

Department of Medicine, Samsung Medical Center,Sungkyunkwan University School of Medicine

Seoul, , South Korea

Countries

South Korea

Central Contacts

Poong-Lyul Rhee, MD,Ph.D.

Role: CONTACT

plrhee@skku.edu

+82-2-3410-3409

Facility Contacts

Poong-Lyul Rhee, M.D, Ph. D

Role: primary

plrhee@skku.edu

+82-2-3410-3409

Other Identifiers

2013-12-026

Identifier Type: -

Identifier Source: org_study_id