Efficacy and Safety of EsoDuo®

Launched by CHONG KUN DANG PHARMACEUTICAL · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called EsoDuo® to see how well it works in controlling symptoms of gastroesophageal reflux disease (GERD), such as heartburn. The trial is currently looking for participants aged 19 and older who have been diagnosed with non-erosive reflux disease or mild erosive reflux disease and have experienced episodes of heartburn. However, if you have had certain esophageal conditions, recent cancer, or specific surgeries, you may not be eligible to join.

If you participate in this trial, you can expect to take EsoDuo® and report on your symptoms over a set period. The goal is to determine how effective and safe the medication is for managing reflux symptoms. This study is open to both men and women, and it aims to help improve treatment options for people suffering from GERD. Your involvement could contribute to valuable research that may benefit others facing similar health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female aged ≥ 19 years
• • 2. Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
• • 3. Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)
• Exclusion Criteria:
• • 1. Surgery history on stomach or esophagus
• • 2. Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
• • 3. Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
• • 4. Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
• • 5. Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
• • 6. Clinically significant Abnormal Lab test
• • 7. Pregnant woman, Breastfeeding woman.