Functional Dyspepsia Clinical Trial
Official title:
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients With Functional Dyspepsia
This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia
| Status | Not yet recruiting |
| Enrollment | 380 |
| Est. completion date | December 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - Men or women = 19 years of age - Patients who diagnosed with functional dyspepsia - Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit Exclusion Criteria: - Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit - Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit - Patients with hypersensitivity to investigational drugs and similar drugs - Pregnant or breastfeeding women |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Wonkwang University Hospital | Iksan | Muwangro 895 |
| Lead Sponsor | Collaborator |
|---|---|
| Dong-A ST Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in NDI-K functional dyspepsia score | Change from baseline at 4 weeks | ||
| Secondary | Change in overall treatment score of patients | Change from baseline at 4 weeks |
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