Evaluation of DA-9701 and DA-9701-R for Treating Functional Dyspepsia in Adults Aged 19 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of DA-9701 in adults with functional dyspepsia, a condition characterized by digestive symptoms. This Phase 4 study focuses on adults aged 19 to 75 who have been diagnosed based on the Rome IV criteria and experience moderate to severe symptoms. The study aims to compare DA-9701 with an active comparator, DA-9701-R, to understand their impact on symptom relief. Participants are randomly assigned to receive either DA-9701 along with a DA-9701-R placebo or DA-9701-R with a DA-9701 placebo. Both treatments are given as one tablet three times daily for four weeks. The study is quadruple-masked, meaning neither the participants, caregivers, investigators, nor outcome assessors know which treatment is being administered. During the study, participants will be assessed using the Gastrointestinal Symptom Score GIS to measure changes in symptom severity at two and four weeks. Quality of life will be evaluated with the Nepean Dyspepsia Index-Korean version NDI-K. Both patients and investigators will provide global assessments at week four. Safety and tolerance will be monitored throughout the treatment period. The total duration of participation is approximately four weeks, with visits scheduled to track progress and collect data.

A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia