DyspepsiaNCT02151708
Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia: Evaluation Using MRI Method
A study testing motilitone in people with Dyspepsia, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- motilitone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 and 70 years of age
- Diagnosed of functional dyspepsia patients by ROME III diagnostic criteria
- Symptom scores three-point by 8 kinds of symptoms on NDI-K table
- Signed written informed consent.
Who cannot join
- Any functional GI diease
- Previous abdominal surgery
- pregnancy or lactation
- Other conditions likely to interfere with study procedures. as judged by the investigator
- Allergic history to motilitone
- Contraindications to MRI
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- Significant cardiopulmonary disease
- Significant renal(serum creatinine level≥1.5 x the upper normal limit) or liver (AST or ALT≥2.5xULN)disease
- Can not be stopped taking medications that gastric motility booster and antacid prior to the start of the study
- Uncontrollable diabetes mellitus (HbA1C>7%)
- Any malignancies within 5 years prior to the start of the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Medicine, Samsung Medical Center,Sungkyunkwan University School of Medicine
Seoul, 135-710
Poong-Lyul Rhee, M.D, Ph. D, +82-2-3410-3409, plrhee@skku.edu
About this study
Official title: 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.
Read the detailed description
Same as above
- Conditions
- Dyspepsia
- Being tested
- Placebo, motilitone
- Keywords
- accommodation, emptying,motilitone
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.
motilitoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| motilitone 90mg | Active comparator | 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. Receives: Drug: motilitone |
| motilitone 180mg | Active comparator | 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. Receives: Drug: motilitone |
| placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation in gastric emptying rate after the test meal
Measured: Evaluation in gastric emptying rate 120min after the test meal
Secondary outcomes (5)
The secondary endpoints are gastric accommodation and symptom improvement.
Measured: This outcome is measured on day 14 after 2 weeks of treatment
Change in total gastric volume (TGV) after the test meal
Measured: 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)
Measured: GE 15min 30min 60min after the test meal.
Change in proximal total gastric volume (TGV) after the test meal
Measured: 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
Measured: The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poong-Lyul Rhee, Samsung Medical Center
- Investigators
- Poong-Lyul Rhee, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151708
- Sponsor's protocol ID
- 2013-12-026
- Status last verified
- Nov 2014
- First submitted
- 28 May 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia:
- ClinicalTrials.gov ID
- NCT02151708
- Acronym / sponsor ID
- 2013-12-026
- Conditions
- Dyspepsia
- Keywords
- accommodation, emptying,motilitone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Same as above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| motilitone 90mg | Active comparator | Drug: motilitoneEligible 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 180mg | Active comparator | Drug: motilitoneEligible 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 | Placebo comparator | Drug: PlaceboEligible 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 and 70 years of age
- Diagnosed of functional dyspepsia patients by ROME III diagnostic criteria
- Symptom scores three-point by 8 kinds of symptoms on NDI-K table
- Signed written informed consent.
Key exclusion criteria (11 listed)
- Any functional GI diease
- Previous abdominal surgery
- pregnancy or lactation
- Other conditions likely to interfere with study procedures. as judged by the investigator
- Allergic history to motilitone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEligible 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 |
| motilitoneEligible 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 180mg, motilitone 90mg |
Primary outcome
Evaluation in gastric emptying rate after the test meal
Time frame: Evaluation in gastric emptying rate 120min after the test meal
5 secondary outcomes
The secondary endpoints are gastric accommodation and symptom improvement.
Time frame: 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.
Gastric emptying rate(GE)
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poong-Lyul Rhee, MD, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motilitone in people with Dyspepsia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Poong-Lyul Rhee, MD,Ph.D. (+82-2-3410-3409, plrhee@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation in gastric emptying rate after the test meal (time frame: Evaluation in gastric emptying rate 120min after the test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.