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

Samsung Medical Center

Status: Completed

Conditions: Dyspepsia

Treatments: Drug: Placebo (for Motilitone); Drug: Motilitone

Study type: Interventional

Funder types: Other

Identifiers

NCT02091635

Motilitone

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. 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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:

  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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Motilitone

Active Comparator group

Description:

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).

Treatment:

Drug: Placebo (for Motilitone)

Placebo (for Motilitone)

Placebo Comparator group

Description:

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).

Treatment:

Drug: Motilitone