Status:
COMPLETED
Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Dyspepsia
Biliary Dysplasia
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
Refractory Functional Dyspepsia (FD) means a state that no symptom was improved in spite of appropriate treatment for the FD. It may be challenging to discriminate the symptoms of FD from the symptom...
Detailed Description
Functional Dyspepsia means a pain or discomfort of epigastrium originated from the stomach or duodenum without any causative organic or metabolic disease. For its standard criteria, "Rome IV diagnosis...
Eligibility Criteria
Inclusion
- Person over 19 years old as of the date of submission
- Among patients with FD diagnosed by the Rome IV criteria, patients with RFD
- Person who have had early satiation and bothersome postprandial fullness for minimum 3 days a week and epigastric pain and epigastric soreness for minimum 1 day a week
- Person with above symptoms that started at least 6 months before and continused for minimum 3 months
- Person having no possible causes of above symptoms including organic disease, structural modification, systemic disease, and endocrinology-metabolic disease
- Person who do not respond to at least 2 general treatments for FD
- Dyspepsia symptoms that can disrupt daily life (global overall symptom scale score =\>5)
- Persons who submitted written consent to participate in this study
Exclusion
- Patient with biliary disease other than bile stone, scraps in the gall and bile tract, and polyps of gallbladder
- Patient with structurally abnormal biliary system from congenital malformation or other reasons
- Patients with endocrinology-metabolic disease that can affect mobility of gastrointestinal tract and biliary system such as diabetes and abnormal thyroid function
- Patient who cannot discontinue any drug that can provoke abdominal symptoms
- Patient with disease or damage in central nervous system (cerebral hemorrhage and cerebral infarction with residual disorder) and autonomic nervous system (vertebrate)
- Patient with renal disorder and electrolyte imbalance
- Patient who received gastrointestinal surgery (excluding appendectomy and hemorrhoidectomy)
- Patient with frequent biliary colic or infection of biliary infection
- Obstructive jaundice patient
- Severe renal disease patient
- Patient with variceal bleeding, hepatic coma, ascites, and needs for acute liver transplantation
- Patient with severe pancreatic disease
- Person scheduled to receive combined administration of below drugs:
- Drug with considerable hepatic toxicity Antacid agent containing cholestyramine, medical charcoal, magnesium and aluminum hydroxide
- alpha-methydopa
- Drug to increase bile secretion of cholesterol ( estrogen, hormonal contraception agent, partial lipid lowering agent), drug to reduce blood cholesterol
- Patient with hypersensitivity to this drug or any component of this drug
- Patient with severe biliary obstruction
- Patient with radiopaque, calcificated bile stone
- Patient with acute cholecystitis
- Patient with peptic ulcer
- Patient with coloenteritis like Crohn disease
- Cholestasis patient
- Patient with abnormality in gallbladder contraction (below 40% of GB ejection fraction)
- Person relevant to below criteria, as results of tests conducted in screening
- Person with BUN exceeding 3 times of normal upper limit
- Person with blood creatinine exceeding 3 times of normal upper limit
- Person with total bilirubin exceeding 3 times of normal upper limit
- Person with direct bilirubin exceeding 3 times of normal upper limit
- Person with AST(sGOT) and ALT(sGPT) exceeding 3 times of normal upper limit
- Person with ALP(alkaline phosphatase) exceeding 3 times of normal upper limit
- Person with GGT(gamma-glutamyl transferase) exceeding 3 times of normal upper limit
- Woman who is pregnant or lactating and women in childbearing age who uses no reliable contraceptive measure or doesn't agree to keep contraception during pregnancy period
- Person who cannot understand purpose and methods of this study such as mental patients or patients with drug and alcohol abuse
- Other persons considered by any investigator to have some difficulties in performing this study
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03844100
Start Date
November 1 2019
End Date
August 4 2021
Last Update
March 22 2022
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13496
2
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea, 06229
3
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450
4
In Ha University Hospital
Incheon, Jung-gu, South Korea, 22332