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Completed

NCT Number: NCT04341454

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

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

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Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWP14012 X mg

Drug

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

DWP14012 X mg placebo

Drug

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

DWP14012 Y mg

Drug

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

DWP14012 Y mg placebo

Drug

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

Primary outcomes

  1. Improvement rate of gastric mucosal erosion

    Time frame: at 2 weeks after the IP administration

    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100

Secondary outcomes

  1. Cure rate of gastric mucosal erosion

    Time frame: at 2 weeks after the IP administration

    Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100

  2. Cure rate of gastric mucosal edema

    Time frame: at 2 weeks after the IP administration

    Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100

  3. Improvement rate of gastric mucosal erythema

    Time frame: at 2 weeks after the IP administration

    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100

  4. Improvement rate of gastric mucosal bleeding

    Time frame: at 2 weeks after the IP administration

    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100

  5. Improvement rate of subjective symptoms

    Time frame: at 2 weeks after the IP administration

    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2020
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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