Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

NCT06948487 | Recruiting

• 1 other identifier: DW_FEX_DB_03
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.

Conditions

Gastritis

Keywords

Acute; Chronic

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with improvement in subjective symptoms

  The proportion of subjects with improvement in subjective symptoms at Week 2 (up to Week 4) compared to baseline.

  2 weeks(up to 4 weeks)

Secondary Outcomes (5)

• Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily)

  2 weeks(up to 4 weeks)

• Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe)

  2 weeks(up to 4 weeks)

• Disappearance rate of subjective symptoms

  2 weeks(up to 4 weeks)

• Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened'

  2 weeks(up to 4 weeks)

• Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient'

  2 weeks(up to 4 weeks)

Study Arms (1)

Fexuclue® Tab

Fexuclue® Tab Fexuclue® Tab Fexuprazan Hydrochloride 10mg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The proportion of subjects with improved subjective symptoms at 2 to 4 weeks after Fexuclue tablet administration for gastritis will be assessed based on patient-reported outcomes. Referring to prior Phase 3 data, a 60% efficacy rate is assumed. Using G-Power 3.1.9.7 with a two-sided significance level of 0.05 and statistical power of 95%, the minimum sample size was calculated to be 10,434. Considering a 25% dropout rate, approximately 13,000 participants will be enrolled.

You may qualify if:

• Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent.
• Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication.
• Subjects who present with at least one subjective symptom requiring medical treatment
• Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.

You may not qualify if:

• Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling.
• Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Masong Kim Internal Medicine Clinic

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Gastritis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jingun Kim, Dr.

  Masong Kim Internal Medicine Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Heui Kim

CONTACT

82-10-2994-5887; 2210325@daewoong.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 29, 2025
• Study Start: June 17, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): June 3, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

KR (1)