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

NCT02151708 | Unknown

• 1 other identifier: 2013-12-026
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.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.

Conditions

Dyspepsia

Keywords

accommodation, emptying,motilitone

Outcome Measures

Primary Outcomes (1)

• Evaluation in gastric emptying rate after the test meal

  Evaluation in gastric emptying rate 120min after the test meal

Secondary Outcomes (5)

• The secondary endpoints are gastric accommodation and symptom improvement.

  This outcome is measured on day 14 after 2 weeks of treatment

• Change in total gastric volume (TGV) after the 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)

  GE 15min 30min 60min after the test meal.

• Change in proximal total gastric volume (TGV) 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

  The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

Placebo DRUG

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

motilitone DRUG

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.

motilitone 180mg; motilitone 90mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

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

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Poong-Lyul Rhee, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Central Study Contacts

Poong-Lyul Rhee, MD,Ph.D.

CONTACT

+82-2-3410-3409; plrhee@skku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

KR (1)