GallstoneNCT04350346
The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
A study testing Motilitone and Gasmotin in people with Gallstone, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Gallstone
- What is being tested?
- Motilitone and Gasmotin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2020to Sep 2021
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 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
Who cannot join
- asymptomatic cholelithiasis
- Gallstones over 3cm
- Acute cholecystitis requires surgery
- pregnant women
- porcelain gallbladder
- Chronic cholecystitis with severe thickening of the gallbladder wall
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Severance hospital
Seoul
Ho Kyoung Hwang, Ph.D.
82+010-3396-1646, DRHHK@yuhs.ac
About this study
Official title: A Prospective, Randomized Controlled Trial of the Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
- (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.
Read more
- (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.
Read the detailed description
At Severance Hospital, patients with cholelithiasis with symptoms of indigestion are divided into the Motilitone® and Gasmotin® groups. Provide sufficient oral and written explanation of the clinical trial and obtain consent from the patient who has revealed his willingness to participate. Randomization uses random numbers, and patient assignment by random numbers is managed by a third party who does not have direct contact with the patient or clinical history, and after obtaining consent, the group according to the random number is given and medication is given. It is provided to. Each drug is prescribed for 6 months. The symptom score check should be completed at the first outpatient visit(3 months after administration). We will Check the following items through abdominal ultrasound examination 6 months after administration.
: Gallbladder wall thickening presence and extent, number of gallstones, maximum diameter of gallstones, presence or absence of sludge. The general blood test (CBD) and general chemical test (SMA) are conducted three times at the first outpatient visit(3 months after administration), and the research expenses for 3 months and 6 months are supported by the research fund. In the final analysis, we compare the symptom scores between the two groups through the Student T-test, and compare the blood test and ultrasound using the Chi-square test. We want to confirm the following three things through this study. ① In patients with cholelithiasis with symptoms of dyspepsia, prospective data on the degree of symptom improvement following motilitone administration can be obtained. ② It is possible to evaluate the degree of relief or exacerbation of gallstones through ultrasound examination. ③ It is expected that it will be effective in improving symptoms and alleviating cholelithiasis in patients with dyspeptic cholelithiasis due to increased gallbladder contractility of motilitone.
- Conditions
- Gallstone
- Being tested
- Motilitone, Gasmotin
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotilitoneDrug
- Ingredients and content: corydalis tuber, pharbitis seed 50% EtOH extracts 30mg
- Dosage method: Usually, adults take 1 tablet 3 times a day orally before meals.
- 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.
GasmotinDrug
- Ingredient and content: mosapride citrate dihydrate 5.29mg (5mg as active ingredient)
- Dosage method: Usually, an adult is orally administered 1 tablet 3 times a day before meals.
- Pharmacological action: mosapride is a selective serotonin-4 (5-HT4) receptor agonist with gastrointestinal stimulating activity, contracting smooth muscle
| Study group | Role | What they receive |
|---|---|---|
| The patient group who taken Motilitone | Active comparator | Not described Receives: Drug: Motilitone |
| The patient group who taken Gasmotin | Active comparator | Not described Receives: Drug: Gasmotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of WBC count (10^3/µL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of RBC count (10^6/µL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Hemoglobin (g/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of BUN (mg/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Glucose (mg/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Albumin (g/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Total bilirubin (mg/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Direct bilirubin (mg/dL), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Amylase (U/L), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Lipase (U/L), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Sodium (mmol/L), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Potassium (mmol/L), before and after the administration
Measured: 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
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Alkaline phosphate (IU/L), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Gamma-glutamyltransferase (IU/L), before and after the administration
Measured: 3months (At the first outpatient visit 3months after administration)
Secondary outcomes (5)
Abdominal ultrasound examination - Change of Gallbladder wall thickening
We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks whether the gallbladder wall is thick or not. The ultrasound findings are compared before and 6 months after administration.
Measured: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Gallbladder wall extent
We will check Abdominal ultrasound examination 6months after administration. If the gallbladder wall was thick at the first visit, ultrasound after 6 months checks how thick the gallbladder wall is. The thickness of the gallbladder wall is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration.
Measured: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Number of gallstones
We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the number of gallstones. The ultrasound findings are compared before and 6 months after administration.
Measured: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Maximum diameter of gallstones
We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the maximum diameter of gallstones. The maximum diameter of gallstones is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration.
Measured: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Presence or Absence of sludge
We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks whether the sludge is in the gallbladder or not. The ultrasound findings are compared before and 6 months after administration.
Measured: 6months (At the second outpatient visit 6months after administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start25 Mar 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350346
- Sponsor's protocol ID
- 4-2019-0728
- Status last verified
- Sep 2020
- First submitted
- 8 Apr 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8174966Sengupta 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.
PubMed 17556905
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of the Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT04350346
- Acronym / sponsor ID
- 4-2019-0728
- Conditions
- Gallstone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- 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.
- (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.
Detailed description
At Severance Hospital, patients with cholelithiasis with symptoms of indigestion are divided into the Motilitone® and Gasmotin® groups. Provide sufficient oral and written explanation of the clinical trial and obtain consent from the patient who has revealed his willingness to participate. Randomization uses random numbers, and patient assignment by random numbers is managed by a third party who does not have direct contact with the patient or clinical history, and after obtaining consent, the group according to the random number is given and medication is given. It is provided to. Each drug is prescribed for 6 months. The symptom score check should be completed at the first outpatient visit(3 months after administration). We will Check the following items through abdominal ultrasound examination 6 months after administration.
: Gallbladder wall thickening presence and extent, number of gallstones, maximum diameter of gallstones, presence or absence of sludge. The general blood test (CBD) and general chemical test (SMA) are conducted three times at the first outpatient visit(3 months after administration), and the research expenses for 3 months and 6 months are supported by the research fund. In the final analysis, we compare the symptom scores between the two groups through the Student T-test, and compare the blood test and ultrasound using the Chi-square test. We want to confirm the following three things through this study. ① In patients with cholelithiasis with symptoms of dyspepsia, prospective data on the degree of symptom improvement following motilitone administration can be obtained. ② It is possible to evaluate the degree of relief or exacerbation of gallstones through ultrasound examination. ③ It is expected that it will be effective in improving symptoms and alleviating cholelithiasis in patients with dyspeptic cholelithiasis due to increased gallbladder contractility of motilitone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patient group who taken Motilitone | Active comparator | Drug: Motilitone |
| The patient group who taken Gasmotin | Active comparator | Drug: Gasmotin |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 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
Key exclusion criteria (11 listed)
- asymptomatic cholelithiasis
- Gallstones over 3cm
- Acute cholecystitis requires surgery
- pregnant women
- porcelain gallbladder
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 |
|---|---|---|
| Motilitone1. 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. | Drug | The patient group who taken Motilitone |
| Gasmotin1. 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 | Drug | The patient group who taken Gasmotin |
Primary outcome
Check symptom improvement
Time frame: 3months (At the first outpatient visit 3months after administration)
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.
Changes in serum concentrations of WBC count (10^3/µL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of RBC count (10^6/µL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Hemoglobin (g/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of BUN (mg/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Glucose (mg/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Albumin (g/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Total bilirubin (mg/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Direct bilirubin (mg/dL), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Amylase (U/L), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Lipase (U/L), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Sodium (mmol/L), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Potassium (mmol/L), before and after the administration
Time frame: 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
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Alkaline phosphate (IU/L), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
Changes in serum concentrations of Gamma-glutamyltransferase (IU/L), before and after the administration
Time frame: 3months (At the first outpatient visit 3months after administration)
5 secondary outcomes
Abdominal ultrasound examination - Change of Gallbladder wall thickening
Time frame: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Gallbladder wall extent
Time frame: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Number of gallstones
Time frame: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Maximum diameter of gallstones
Time frame: 6months (At the second outpatient visit 6months after administration)
Abdominal ultrasound examination - Presence or Absence of sludge
Time frame: 6months (At the second outpatient visit 6months after administration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 8174966Catnach 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.
- Background: PubMed 17556905Sengupta 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.
- Individual participant dataSharing planned: No
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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.
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 and Gasmotin in people with Gallstone, run by Yonsei University 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 3 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 30 Sep 2020. 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. 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 Ho Kyoung Hwang, Ph.D. (82+ 10-3396-1646, DRHHK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Check symptom improvement (time frame: 3months (At the first outpatient visit 3months after administration)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350346, which also lists 2 linked publications.
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 30 Sep 2020; AzTrials last refreshed its copy on 1 Nov 2026.