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

November 24, 2014 updated by: Poong-Lyul Rhee, Samsung Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Same as above

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Poong-Lyul Rhee, MD,Ph.D.
  • Phone Number: +82-2-3410-3409
  • Email: plrhee@skku.edu

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Department of Medicine, Samsung Medical Center,Sungkyunkwan University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: motilitone 90mg
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.
Active Comparator: motilitone 180mg
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evaluation in gastric emptying rate after the test meal
Time Frame: Evaluation in gastric emptying rate 120min after the test meal
Evaluation in gastric emptying rate 120min after the test meal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The secondary endpoints are gastric accommodation and symptom improvement.
Time Frame: This outcome is measured on day 14 after 2 weeks of treatment
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.
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.
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
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
The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Poong-Lyul Rhee, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-12-026

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