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

Dyspepsia Clinical Trial

Official title:

Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02151708
• Other study ID #: 2013-12-026
• Status: Not yet recruiting
• Phase: N/A
• First received: May 28, 2014
• Last updated: November 24, 2014
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: Samsung Medical Center
• Contact: Poong-Lyul Rhee, MD,Ph.D.
• Phone: +82-2-3410-3409
• Email: plrhee[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

Same as above

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Medicine, Samsung Medical Center,Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation in gastric emptying rate after the test meal		Evaluation in gastric emptying rate 120min after the test meal	No
Secondary	The secondary endpoints are gastric accommodation and symptom improvement.		This outcome is measured on day 14 after 2 weeks of treatment	No
Secondary	Change in total gastric volume (TGV) after the test meal		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.	No
Secondary	Gastric emptying rate(GE)		GE 15min 30min 60min after the test meal.	No
Secondary	Change in proximal total gastric volume (TGV) after the test meal		The chanfe is defined as difference between proximal TGV 15min after the test meal	No
Secondary	Change in proximal to distal total gastric volume (TGV) ratio afrer the test meal		The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal	No