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

Primary Purpose

Dyspepsia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo (for Motilitone)

Motilitone

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring accommodation, emptying, motilitone

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Motilitone

Placebo (for Motilitone)

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in total gastric volume (TGV) after the test meal

Secondary Outcome Measures

Gastric emptying (GE) rate

Change in proximal TGV after the test meal

Change in proximal to distal TGV ratio after the test meal

Full Information

NCT ID

NCT02091635

First Posted

March 6, 2014

Last Updated

March 18, 2014

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02091635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia

Keywords

accommodation, emptying, motilitone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Motilitone

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Placebo (for Motilitone)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Name(s)

Placebo (for Motilitone)

Other Intervention Name(s)

Sugar pill manufactured to mimic Motilitone 60mg tablet

Intervention Description

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

Intervention Name(s)

Motilitone

Other Intervention Name(s)

DA-9701

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in total gastric volume (TGV) after the test meal

Time Frame

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.

Secondary Outcome Measure Information:

Title

Gastric emptying (GE) rate

Time Frame

This outcome is measured on day 7 after 5 days of treatment

Title

Change in proximal TGV after the test meal

Time Frame

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.

Title

Change in proximal to distal TGV ratio after the test meal

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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: any functional GI disease or previous abdominal surgery diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment significant cardiopulmonary diseases or any malignancies 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 taking medications that may alter gastric function within 2 weeks prior to the start of the study pregnancy or lactation females with inadequate contraception during the study period contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip) allergic history to motilitone other conditions likely to interfere with study procedures, as judged by the investigator

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26402448

Citation

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.

Results Reference

derived

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

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