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Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients

Primary Purpose

Dyspepsia, Biliary Dysplasia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

efficacy and safety of CNU® Capsule

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Refractory Functional Dyspepsia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
- 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 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:
- 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

Sites / Locations

CHA Bundang Medical Center
Gangnam Severance Hospital
Dongtan Sacred Heart Hospital
In Ha University Hospital
Soon Chun Hyang University Hospital, Cheonan
Gachon University Gil Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Refractory Functional Dyspepsia

Arm Description

Patients with FD diagnosed by the Rome IV criteria, patients with Refractory Functional Dyspepsia 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)

Outcomes

Primary Outcome Measures

Improvement of symptoms

The primary outcome variable will be the percentage of subjects to report that they are improved or unchanged or deteriorated or No assessable in overall symptoms compared to baseline on a 7-point Global Overall Symptom Scale (GOS). The GOS is assessed on a 7-point scale, with the severity scale from 1 (Normal, not at all ill) through to 7 (Among the most severely ill patients).

Secondary Outcome Measures

The Total Number of subjects Experiencing at Least one Adverse Event During the study

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Full Information

NCT ID

NCT03844100

First Posted

December 11, 2018

Last Updated

March 21, 2022

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03844100

Brief Title

Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients

Official Title

Multi-center Single Sided Preliminary Study to Evaluate Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

August 4, 2021 (Actual)

Study Completion Date

August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia, Biliary Dysplasia

Keywords

Refractory Functional Dyspepsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

single arm: patients with refractory functional dyspepsia

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with Refractory Functional Dyspepsia

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

efficacy and safety of CNU® Capsule

Other Intervention Name(s)

CNU® Capsule (Trihydrated magnesium salt of kenodeoxycholic acid and ursodeoxycholic acid, 250 mg)

Intervention Description

All subjects take 250mg CNU capsule orally 1 capsule per time, 2 times a day (morning, evening / at meal or after meal) for 12 weeks.

Primary Outcome Measure Information:

Title

Improvement of symptoms

Description

Time Frame

12weeks after CNU capsules

Secondary Outcome Measure Information:

Title

The Total Number of subjects Experiencing at Least one Adverse Event During the study

Description

Time Frame

for 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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: 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

Facility Information:

Facility Name

CHA Bundang Medical Center

City

Seongnam

State/Province

Bundang-gu

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Gangnam Severance Hospital

City

Seoul

State/Province

Gangnam-gu

ZIP/Postal Code

06229

Country

Korea, Republic of

Facility Name

Dongtan Sacred Heart Hospital

City

Hwaseong-si

State/Province

Gyeonggi-do

ZIP/Postal Code

18450

Country

Korea, Republic of

Facility Name

In Ha University Hospital

City

Incheon

State/Province

Jung-gu

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Soon Chun Hyang University Hospital, Cheonan

City

Cheonan

State/Province

Namdong-gu

ZIP/Postal Code

31151

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

State/Province

Namdong-gu

ZIP/Postal Code

21565

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

The data will become available untill all patients are enrolled and be open to all researchers for 1 year

IPD Sharing Access Criteria

Only researchers.

Learn more about this trial

Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients

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