Multi-center Single Sided Preliminary Study to Evaluate Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients
Multi-center Single Sided Preliminary Study to Evaluate Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients
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 symptoms of bile dyspepsia resulting from the biliary system. As the bile dyspepsia may induce epigastralgia as with functional dyspepsia and both imaging medical tests and blood tests show normal findings, it is difficult to discriminate it from the FD with only these tests.
Thus this study intends to perform a therapeutic use clinical study for efficacy and safety on symptom improvement by administrating CNU capsule to the patients with RFD.
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 criteria" was used, where more than on symptoms including bothersome postprandial fullness, early satiation, epigastric pain, and epigastric soreness should have been elicited at least 6 months before and continued for at least 3 months in total.
Refractory Functional Dyspepsia means a state that no symptom was improved in spite of appropriate treatment for the functional dyspepsia.
The pathogenesis of Functional Dyspepsia has not been fully identified yet. Its standard therapies include prokinetics, analgesics, H2-receptor antagonists, proton pump inhibitors, antacids, serotonin receptor antagonists, proton pump inhibitors, antacids, serotonin receptor antagonists, and antidepressants. As these therapies has lower efficacy and drug related adverse reactions, the RFD patients who do not respond to medication need another therapeutic option.
It may be challenging to discriminate the symptoms of FD from the symptoms of bile dyspepsia resulting from the biliary system. As the bile dyspepsia may induce epigastralgia as with functional dyspepsia and both imaging medical tests and blood tests show normal findings, it is difficult to discriminate it from the FD with only these tests.
Therefore even though the epigastralgia or upper abdominal discomfort met the Rome IV criteria for the FD, the possibility that it, in part was actually resulted from the bile dyspepsia cannot be eliminated.
The CNU capsule is a choleretic used for bile dyspepsia as a complex agent of trihydrated magnesium salt of kenodeoxycholic acid and ursodeoxycholic acid, which are being marketed.
Thus this study intends to perform a therapeutic use clinical study for efficacy and safety on symptom improvement by administrating CNU capsule to the patients with RFD.
Inclusion Criteria:
Person over 19 years old as of the date of submission
Among patients with FD diagnosed by the Rome IV criteria, patients with RFD
Persons who submitted written consent to participate in this study
Exclusion Criteria:
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:
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
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