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

Samsung Medical Center

Status: Unknown

Conditions: Dyspepsia

Treatments: Drug: motilitone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02151708

2013-12-026

Details and patient eligibility

About

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.

Full description

Same as above

Enrollment: 78 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 3 patient groups, including a placebo group

motilitone 90mg

Active Comparator group

Description:

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.

Treatment:

Drug: motilitone

motilitone 180mg

Active Comparator group

Description:

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.

Treatment:

Drug: motilitone

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo