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

NCT03844100 | Completed Phase 1 DMC

• 1 other identifier: 3-2018-0300
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

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.

Conditions

Dyspepsia; Biliary Dysplasia

Keywords

Refractory Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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).

  12weeks after CNU capsules

Secondary Outcomes (1)

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

  for 12 weeks

Study Arms (1)

Patients with Refractory Functional Dyspepsia

EXPERIMENTAL

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)

Drug: efficacy and safety of CNU® Capsule

Interventions

efficacy and safety of CNU® Capsule DRUG

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.

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

Patients with Refractory Functional Dyspepsia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (6)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06229, South Korea

Location

Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

In Ha University Hospital

Incheon, Jung-gu, 22332, South Korea

Location

Soon Chun Hyang University Hospital, Cheonan

Cheonan, Namdong-gu, 31151, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

1-(2-chloroethyl)-1-nitrosourea; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, MD, PhD

Model Details: single arm: patients with refractory functional dyspepsia

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: February 18, 2019
• Study Start: November 1, 2019
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available untill all patients are enrolled and be open to all researchers for 1 year
• Access Criteria: Only researchers.

Locations

KR (6)