Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia: Evaluation Using MRI Method
Status:
Unknown status
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
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.