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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091635
• Other study ID #: Motilitone
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: March 18, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

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 (for Motilitone)
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).
• Motilitone
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).

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	Change in total gastric volume (TGV) after the test meal		This outcome is measured on day 7 after 5days 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 (GE) rate		This outcome is measured on day 7 after 5 days of treatment	No
Secondary	Change in proximal TGV after the test meal		This outcome is mesured on day 7 after 5 days of treatment. The change is defined as difference between proximal TGV 15 min after the test meal and at the pre-test meal.	No
Secondary	Change in proximal to distal TGV ratio after the test meal		This outcome is measured on day 7 after 5 days of treatment. The change is defined as difference between proximal to distal TGV ratio 15 min after the test meal and at the pre-test meal.	No