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Efficacy of ESODUO in Patients with erosive esophagitis

Efficacy and Safety of ESODUO in Patients with erosive esophagitis: A Prospective Open-Label O bservation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008913
Enrollment
60
Registered
2023-10-30
Start date
2023-10-17
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Hallym University Medical Center-Kangnam
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who are between 19 and 85 years of age as of the date of obtaining written consent 2) Those diagnosed with erosive gastroesophageal reflux disease (LA grade A-D) on upper gastrointestinal endoscopy within the last 2 weeks as of Visit 2 (enroll date) 3) A person who can understand and follow instructions and participate in the entire clinical trial period 4) Those who voluntarily decide to participate and agree in writing to the clinical trial subject consent form

Exclusion criteria

Exclusion criteria: 1) esophagogastroduodenoscopy shows gastrointestinal bleeding, perforation, esophageal stricture, ulcer stricture, pyloric stricture, esophagogastric varices, long segment Barrett esophagus (LSBE) exceeding 3 cm, dysplastic changes of any grade in the esophagus, those with confirmed malignant tumor 2) Patients diagnosed with eosinophilic esophagitis 3) Patients diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), etc. within the past 3 months, or patients suspected of having irritable bowel syndrome 4) Those who have previously undergone surgery to suppress gastric acid secretion or surgery on the stomach or esophagus 5) Patients who have taken concurrent medications (PPI, P-CAB, histamine 2 receptor antagonist, anticholinergic, antacid, mucosal protector, gastrointestinal motility stimulant) within the past 2 weeks as of Visit 2 (enroll date) 6) Patients who must continue to take nonsteroidal anti-inflammatory drugs (NSAIDs) and antithrombotic drugs during the trial period 7) Pregnant or lactating women, or female patients who do not intend to use contraception during the trial period.

Design outcomes

Primary

MeasureTime frame
evaluating the reduction rate in GERD-HRQL score

Secondary

MeasureTime frame
evaluating the GERD-HRQL score ;evaluating the GERD-Q score ;Evaluate the degree of improvement by evaluating the rate of decrease in GERD-HRQL score after 8 weeks compared to baseline, evaluate change in GERD-HRQL score, and evaluate change in GERDQ score;adverse drug reaction

Countries

Korea, Republic of

Contacts

Public ContactChang Kyo Oh

Hallym University Medical Center-Kangnam

ckdryekd@gmail.com+82-2-829-5510

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026