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Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

NCT ID: NCT05842408

Last Updated: 2024-12-13

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

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-09-04

Brief Summary

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

administered once daily for 4weeks

Group Type EXPERIMENTAL

DA-5212

Intervention Type DRUG

Test drug: DA-5212

DA-5212-R

administered once daily for 4weeks

Group Type OTHER

DA-5212-R

Intervention Type DRUG

Control drug: DA-5212-R

Interventions

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DA-5212

Test drug: DA-5212

Intervention Type DRUG

DA-5212-R

Control drug: DA-5212-R

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wonkwang University Hospital

Iksan, Muwangro 895, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA5212_FDQ_III

Identifier Type: -

Identifier Source: org_study_id