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

NCT02091635 | Completed

• 1 other identifier: Motilitone
• Study Type: interventional
• Target: 40
• 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. 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

Keywords

accommodation, emptying, motilitone

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• Gastric emptying (GE) rate

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

• Change in proximal TGV after the test meal

  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.

• Change in proximal to distal TGV ratio after the test meal

  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.

Study Arms (2)

Motilitone

ACTIVE COMPARATOR

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).

Drug: Placebo (for Motilitone)

Placebo (for Motilitone)

PLACEBO COMPARATOR

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).

Drug: Motilitone

Interventions

Placebo (for Motilitone) 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).

Also known as: Sugar pill manufactured to mimic Motilitone 60mg tablet

Motilitone

Motilitone 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).

Also known as: DA-9701

Placebo (for Motilitone)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

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

Related Publications (1)

• 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.

  PMID: 26402448 DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

Sugars; Tablets; DA-9701

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbohydrates; Dosage Forms; Pharmaceutical Preparations

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: March 6, 2014
• First Posted: March 19, 2014
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

KR (1)