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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04784910

Collaborator

(none)

416

Enrollment

Location

Arms

Anticipated Duration (Months)

34.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer	Drug: DWP14012 20mg Drug: Lansoprazole 15 mg Drug: DWP14012 20mg placebo Drug: Lansoprazole 15 mg placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

416 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator [at 24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04784910

Other Study ID Numbers:

DW_DWP14012304

First Posted:

Mar 5, 2021

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2021