Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

D

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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