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Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

NCT ID: NCT04341454

Last Updated: 2021-12-21

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

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2021-09-16

Brief Summary

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The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Detailed Description

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This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Conditions

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Acute Gastritis Chronic Gastritis

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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DWP14012 X mg QD

* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
* Evening: 1 tablet of DWP14012 Y mg placebo

Group Type EXPERIMENTAL

DWP14012 X mg

Intervention Type DRUG

DWP14012 X mg, tablet, orally, once daily for 2 weeks

DWP14012 Y mg placebo

Intervention Type DRUG

DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

DWP14012 Y mg BID

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
* Evening: 1 tablet of DWP14012 Y mg

Group Type EXPERIMENTAL

DWP14012 X mg placebo

Intervention Type DRUG

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

DWP14012 Y mg

Intervention Type DRUG

DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

placebo

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
* Evening: 1 tablet of DWP14012 Y mg placebo

Group Type PLACEBO_COMPARATOR

DWP14012 X mg placebo

Intervention Type DRUG

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

DWP14012 Y mg placebo

Intervention Type DRUG

DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

Interventions

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DWP14012 X mg

DWP14012 X mg, tablet, orally, once daily for 2 weeks

Intervention Type DRUG

DWP14012 X mg placebo

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

Intervention Type DRUG

DWP14012 Y mg

DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

Intervention Type DRUG

DWP14012 Y mg placebo

DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults between 19 and 75 years old based on the date of written agreement
* Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
* Those who had experienced one or more subjective symptoms of gastritis

Exclusion Criteria

* Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
* Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 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

References

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Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.

Reference Type DERIVED
PMID: 36789577 (View on PubMed)

Other Identifiers

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DW_DWP14012305

Identifier Type: -

Identifier Source: org_study_id