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

NCT ID: NCT02091635

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Placebo (for Motilitone)

Intervention Type: DRUG

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).

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).

Group Type: PLACEBO_COMPARATOR

Motilitone

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Sugar pill manufactured to mimic Motilitone 60mg tablet; DA-9701

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Poong-Lyul Rhee

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Countries

South Korea

References

Min YW, Min BH, Kim S, Choi D, Rhee PL. Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 24;10(9):e0138927. doi: 10.1371/journal.pone.0138927. eCollection 2015.

Reference Type: DERIVED

PMID: 26402448 (View on PubMed)

Other Identifiers

Motilitone

Identifier Type: -

Identifier Source: org_study_id