Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Functional Dyspepsia

Treatments: Drug: DWJ1252; Drug: Gasmotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03024086

DW_DWJ1252002

Details and patient eligibility

About

The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.

Enrollment: 124 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male of female of at least 19 years old
• Patient with functional dyspepsia met the ROME III criteria

Exclusion criteria

• Patients with previous gastrointestinal surgery
• Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
• Patients with history of gastrointestinal cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

124 participants in 2 patient groups

DWJ1252

Experimental group

Description:

DWJ1252 + Placebo of Gasmotin

Treatment:

Drug: DWJ1252

Gasmotin

Active Comparator group

Description:

Gasmotin + Placebo of DWJ1252

Treatment:

Drug: Gasmotin