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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: DWP14012 20mg; Drug: Lansoprazole 15 mg placebo; Drug: Lansoprazole 15 mg; Drug: DWP14012 20mg placebo

• Study Type: Interventional
• Enrollment (Anticipated): 416
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ChangKeun Lee, M.D, Ph.D.; Phone Number: 02-3010-3284; Email: cklee@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female adults aged ≥ 19 years at the time of informed consent
2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
3. Subjects with at least one of the following risk factors for ulcer development at screening.
4. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWP14012 20mg; orally, once daily	Drug: DWP14012 20mg; DWP14012 20mg, tablet, orally, once daily for up to 24 weeks; Drug: Lansoprazole 15 mg placebo; Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Active Comparator: Lansoprazole 15mg; orally, once daily	Drug: Lansoprazole 15 mg; Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks; Drug: DWP14012 20mg placebo; DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator	at 12 weeks
Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24	at 12, 24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: DW_DWP14012304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No