A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia

NCT07016269 | Recruiting Phase 4

• 1 other identifier: MMP-402
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 500 mg administration in patients with biliary dyspepsia

Conditions

Biliary Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Symptom improvement rate at Week 24 using the Global Overall Symptom Scale (GOS) in patients with biliary dyspepsia

  * Description: The Global Overall Symptom Scale assesses the overall severity of upper abdominal symptoms such as pain or discomfort, bloating, excessive belching, and nausea. Symptoms are rated on a 7-point Likert scale, where 1 = no symptoms and 7 = very severe symptoms. * Outcome Definition: Improvement is defined as a decrease of 2 or more points compared to baseline. * Unit of Measure: Percentage of participants with ≥2-point reduction

  Baseline and Week 24

Secondary Outcomes (1)

• 1. Symptom improvement rate using the GOS in patients with biliary dyspepsia 2. Change in dyspepsia symptom scores using the NDI-K 3. Change in quality of life scores using the NDI-K

  Baseline, Week 4, Week 12, and Week 24

Study Arms (2)

CnU capsule 500 mg(250mg 2 capsule)

EXPERIMENTAL

Drug: CnU capsule 500 mg(250mg 2 capsule)

CnU placebo capsule 500 mg(250mg 2 capsule)

PLACEBO COMPARATOR

Drug: CnU placebo capsule 500 mg(250mg 2 capsule)

Interventions

CnU capsule 500 mg(250mg 2 capsule) DRUG

According to the randomly assigned treatment groups, the medication will be administered orally at a dose of 500 mg (2 capsules) once daily for a total of 24 weeks, preferably at the same time each day after meals.

CnU capsule 500 mg(250mg 2 capsule)

CnU placebo capsule 500 mg(250mg 2 capsule) DRUG

According to the randomly assigned treatment groups, the medication will be administered orally at a dose of 500 mg (2 capsules) once daily for a total of 24 weeks, preferably at the same time each day after meals.

CnU placebo capsule 500 mg(250mg 2 capsule)

Eligibility Criteria

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

You may qualify if:

• Individuals who have voluntarily agreed to participate in this clinical trial
• Adults aged 19 years and older
• Individuals with pain localized to the epigastrium and/or right upper quadrant, as defined by the ROME IV diagnostic criteria
• Rome IV criteria(Functional gallbladder and sphincter of Oddi disorders Diagnostic criteria) 1) Builds up to a steady level and lasts 30 minutes or longer 2) Occurring at different intervals (not daily) 3) Severe enough to interrupt daily activities or lead to an emergency department visit 4) Not significantly (\<20%) related to bowel movements 5) Not significantly (\<20%) relieved by postural change or acid suppression
• Supportive criteria:
• The pain may be associated with:
• \) Nausea and vomiting 2) Radiation to the back and/or right infrasubscapular region 3) Waking from sleep
• \. Individuals without any organic lesions on abdominal ultrasonography performed during screening that could explain biliary colic symptoms due to gallstones

You may not qualify if:

• \. Medical History
• Patients with frequent biliary colic or biliary tract infections (e.g., severe pancreatic changes such as ileal resection, surgery, or partial ileitis, which may alter the composition of enterohepatic bile acid circulation).
• Patients with obstructive jaundice.
• Patients with liver disease.
• Patients with severe renal disease.
• Patients with severe biliary obstruction (due to the potential choleretic effect, symptoms may worsen).
• Patients with underlying conditions that may worsen biliary obstruction (e.g., cholangiocarcinoma, cholangitis, biliary cysts).
• Patients with acute cholecystitis.
• Patients with a clear etiology of dyspepsia (e.g., those with endoscopically or clinically confirmed GI abnormalities such as gastric ulcer, gastroparesis; regular NSAID users; or those with prominent heartburn).
• Patients with peptic ulcer disease (due to the potential for mucosal irritation and symptom aggravation).
• Patients with inflammatory bowel diseases such as Crohn's disease.
• Patients with cholestasis.
• Patients with abnormal gallbladder contractility.
• Patients with a history of malignancy within 5 years prior to screening.
• Patients with a history of gastrointestinal surgery.

Sponsors & Collaborators

• Myungmoon Pharma. Co. Ltd.: lead

Study Sites (6)

Pusan National University Hospital

Busan, South Korea

RECRUITING

CHA Bundang Medical Center

Gyeonggi-do, South Korea

RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

RECRUITING

Soonchunhyang University Cheonan Hospital

Gyeonggi-do, South Korea

RECRUITING

Inha University Hospital

Incheon, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

1-(2-chloroethyl)-1-nitrosourea

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 11, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

KR (6)