An interventional study of Placebo and motilitone in Dyspepsia, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-25.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
Same as above
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's planned enrollment of 78 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
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.
Evaluation in gastric emptying rate after the test meal
Time frame: Evaluation in gastric emptying rate 120min after the test meal
The secondary endpoints are gastric accommodation and symptom improvement.
Time frame: This outcome is measured on day 14 after 2 weeks of treatment
Change in total gastric volume (TGV) after the test meal
Time frame: 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)
Time frame: GE 15min 30min 60min after the test meal.
Change in proximal total gastric volume (TGV) after the test meal
Time frame: 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
Time frame: The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsung Medical Center