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OpenTrials
Completed

NCT Number: NCT04784910

Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female adults aged ≥ 19 years at the time of informed consent
  • Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
  • Subjects with at least one of the following risk factors for ulcer development at screening.
  • Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.

Exclusion criteria

  • Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
  • Subjects who have undergone gastroduodenal surgery or total small bowel resection
  • Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
  • Subjects who have had a malignant tumor in the last 5 years
  • Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Treatment and study plan

DWP14012 20mg

Drug

DWP14012 20mg, tablet, orally, once daily for up to 24 weeks

Lansoprazole 15 mg

Drug

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

DWP14012 20mg placebo

Drug

DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Lansoprazole 15 mg placebo

Drug

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

Primary outcomes

  1. Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator

    Time frame: at 24 weeks

Secondary outcomes

  1. Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator

    Time frame: at 12 weeks

  2. Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24

    Time frame: at 12, 24 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Jul 8, 2024

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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