Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

NCT ID: NCT03024086

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2017-04-25

Brief Summary

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

Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWJ1252

DWJ1252 + Placebo of Gasmotin

Group Type EXPERIMENTAL

DWJ1252

Intervention Type DRUG

DWJ1252 and Placebo of Gasmotin

Gasmotin

Gasmotin + Placebo of DWJ1252

Group Type ACTIVE_COMPARATOR

Gasmotin

Intervention Type DRUG

Gasmotin and Placebo of DWJ1252

Interventions

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DWJ1252

DWJ1252 and Placebo of Gasmotin

Intervention Type DRUG

Gasmotin

Gasmotin and Placebo of DWJ1252

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanyang University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1252002

Identifier Type: -

Identifier Source: org_study_id

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