The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia

NCT04350346 | Unknown DMC

• 1 other identifier: 4-2019-0728
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

• (Cause of cholelithiasis) Recently, the average age has increased, and the occurrence of gallstones has increased as the dietary life has been westernized due to the improvement of socio-economic level. When cholesterol increases, the occurrence of gallstones increases. Factors include high-calorie high-fat diet, increasing age, women, pregnant women, obesity, and oral contraceptives. There are cases. As another cause, gallstones occur well even when bile stasis occurs due to a decrease in motility of the gallbladder. These are conditions that lower mobility. And cholelithiasis has a genetic tendency in about 30%. In addition, since the eating habits of the family are similar, the genetic factors and the eating habits overlap, which often leads to the occurrence of cholelithiasis in the family.
• (symptoms of cholelithiasis) In most cases, complaints of non-specific digestive system symptoms, such as abdominal bloating, nausea, and especially indigestion after fatty diet, are often observed. According to domestic reports, the nonspecific symptoms complained by patients with cholelithiasis were indigestion, flatulence, frequent belching, nausea, loss of appetite, diarrhea, and vomiting. In general, many healthy people without gallstones complain of non-specific digestive system symptoms in 50% of cases, and there is a possibility that functional gastrointestinal diseases such as dyspepsia, peptic ulcer, and gastritis may be accompanied by these digestive system symptoms. It is difficult to know whether it is unrelated to gallstones. Symptoms caused by typical cholelithiasis usually have a characteristic that they often improve on their own after a few hours, and the start and end of the symptoms are relatively clear and repeatedly occur. In addition, various symptoms are displayed depending on the presence or absence of inflammation and progression.
• (Principle of treatment of cholelithiasis)
• Medical treatment: Medical treatment of gallstones is a method of dissolving using drugs to treat cholesterol gallstones in gallbladder stones. In 1973, Nakano et al. \[1\] published the first example of dissolving cholesterol gallstones using ursodeoxycholic acid (UDCA). Currently, UDCA is the only drug administered to patients with asymptomatic or mild symptoms of cholelithiasis in actual clinical practice, and there is no specific prescription drug.
• Surgical treatment: In the case of indications of cholecystectomy, acute cholecystitis, severe symptoms, chronic cholecystitis with severe thickening of the gallbladder wall, repeated and severe symptoms, porcelain gallbladder, Patients with gallstones of 3 cm or more in size, patients with anomalous pancreato-biliary duct unions, or gallbladder polyps.
• (Study on increasing gallbladder contractility) So far, there have been studies that some drugs increase or decrease gallbladder contractility. Catnach SM et al. \[2\] reported that erythromycin increased gallbladder contractility in patients with autonomic neuropathy due to diabetes. Sengupta S et al. \[3\] reported that indoramin (α-adrenergic antagonist), a prokinetic agent, increased gallbladder contractility in patients with cholelithiasis, resulting in a significant decrease in gallbladder volume. Motilitone® developed in Korea is a gastrointestinal motility stimulator that stimulates 5-HT4 receptors to increase acetylcholine secretion and has a mechanism of contracting smooth muscles, improving symptoms in patients with functional dyspepsia in cholelithiasis It is expected to be able to give, and it is thought to have the effect of preventing the crystallization of bile acids due to an increase in the gallbladder contractility, thereby preventing the formation of gallstones and preventing newly generated gallstones. To date, there are no special drugs for dyspepsia or pain improvement in patients with cholelithiasis. It is hypothesized that administration of motilitone® will increase the contractile capacity of the gallbladder, thereby improving digestion and preventing further formation of gallstones. As a control group, Gasmotin® was administered to improve functional dyspepsia, and the degree of symptom improvement was measured and compared by completing the Symptom Score Questionnaire for Indigestion between the two groups.

Conditions

Gallstone

Outcome Measures

Primary Outcomes (16)

• Check symptom improvement

  The symptom score check should be completed at the first outpatient visit 3 months after administration. Nepean Dyspepsia Index- Korean version will be used to check the patient's indigestion symptoms. The questionnaire contains the following gastrointestinal symptoms How often it happened / how severe the symptoms were / how much it bothered you There are five (or six) answers. Gastrointestinal symptoms included Abdominal pain, Abdominal discomfort, Having a sour stomach, Heart burn, A Spasm of the stomach, Chest pain, Early fullness, Gastric acid reflux, Satiety after eating, pressure in the upper abdomen, Bloating of the upper abdomen, Nausea, Vomiting, Burp, Hard to breathe. The answer can be selected in 5 (6) numbers; from 0 to 4 (5). We will check the total score with the sum of each score. The symptom score is compared before and 3 months after administration.

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of WBC count (10^3/µL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of RBC count (10^6/µL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Hemoglobin (g/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of BUN (mg/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Glucose (mg/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Albumin (g/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Total bilirubin (mg/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Direct bilirubin (mg/dL), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Amylase (U/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Lipase (U/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Sodium (mmol/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Potassium (mmol/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Alkaline phosphate (IU/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

• Changes in serum concentrations of Gamma-glutamyltransferase (IU/L), before and after the administration

  3months (At the first outpatient visit 3months after administration)

Secondary Outcomes (5)

• Abdominal ultrasound examination - Change of Gallbladder wall thickening

  6months (At the second outpatient visit 6months after administration)

• Abdominal ultrasound examination - Gallbladder wall extent

  6months (At the second outpatient visit 6months after administration)

• Abdominal ultrasound examination - Number of gallstones

  6months (At the second outpatient visit 6months after administration)

• Abdominal ultrasound examination - Maximum diameter of gallstones

  6months (At the second outpatient visit 6months after administration)

• Abdominal ultrasound examination - Presence or Absence of sludge

  6months (At the second outpatient visit 6months after administration)

Study Arms (2)

The patient group who taken Motilitone

ACTIVE COMPARATOR

Drug: Motilitone

The patient group who taken Gasmotin

ACTIVE COMPARATOR

Drug: Gasmotin

Interventions

Motilitone DRUG

1. Ingredients and content: corydalis tuber, pharbitis seed 50% EtOH extracts 30mg 2. Dosage method: Usually, adults take 1 tablet 3 times a day orally before meals. 3. Pharmacological action: * It stimulates 5-HT4 receptor as a gastrointestinal motility accelerator to increase acetylcholine secretion and contract smooth muscle. * Stimulates stomach smooth muscle contraction by suppressing the effect of dopamine on acetylcholine secretion by inhibiting D2 receptor ③ It shows a pharmacological action that stimulates gastrointestinal movement by acting in combination with 5-HT1A / B receptor.

The patient group who taken Motilitone

Gasmotin DRUG

1. Ingredient and content: mosapride citrate dihydrate 5.29mg (5mg as active ingredient) 2. Dosage method: Usually, an adult is orally administered 1 tablet 3 times a day before meals. 3. Pharmacological action: mosapride is a selective serotonin-4 (5-HT4) receptor agonist with gastrointestinal stimulating activity, contracting smooth muscle

The patient group who taken Gasmotin

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old to under 75
• Patients with dyspepsia in patients with cholelithiasis
• Patients who consented to this study and conducted questionnaires and tests during follow up

You may not qualify if:

• asymptomatic cholelithiasis
• Gallstones over 3cm
• Acute cholecystitis requires surgery
• pregnant women
• porcelain gallbladder
• Chronic cholecystitis with severe thickening of the gallbladder wall
• Patients with anomalous pancreato-biliary duct union,
• When other physicians believe that surgery is necessary
• Patients with a history of hypersensitivity to "motilitone" or its components
• ; Since this drug contains lactose, galactose intolerance, Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption.
• Hepatitis patients (Hepatitis carriers, cirrhosis patients) or suspected liver failure (AST, ALT levels are 1.5 times or more of normal values)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Severance hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

• Catnach SM, Ballinger AB, Stevens M, Fairclough PD, Trembath RC, Drury PL, Watkins PJ. Erythromycin induces supranormal gall bladder contraction in diabetic autonomic neuropathy. Gut. 1993 Aug;34(8):1123-7. doi: 10.1136/gut.34.8.1123.

  PMID: 8174966 BACKGROUND

• Sengupta S, Modak P, McCauley N, O'Donnell LJ. Prokinetic effect of alpha-adrenergic antagonist, and beta-adrenergic antagonist on gall-bladder motility in humans with gall-stone disease. Eur J Gastroenterol Hepatol. 2007 Jul;19(7):581-3. doi: 10.1097/MEG.0b013e32811ec044.

  PMID: 17556905 BACKGROUND

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ho Kyoung Hwang, Ph.D.

CONTACT

82+ 10-3396-1646; DRHHK@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 17, 2020
• Study Start: March 25, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)