Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Functional Dyspepsia

Treatments: Drug: DA-5212-R; Drug: DA-5212

Study type: Interventional

Funder types: Industry

Identifiers

NCT05842408

DA5212_FDQ_III

Details and patient eligibility

About

This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia

Enrollment: 384 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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384 participants in 2 patient groups

DA-5212

Experimental group

Description:

administered once daily for 4weeks

Treatment:

Drug: DA-5212

DA-5212-R

Other group

Description:

administered once daily for 4weeks

Treatment:

Drug: DA-5212-R