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

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04784910
• Other study ID #: DW_DWP14012304
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: ChangKeun Lee, M.D, Ph.D.
• Phone: 02-3010-3284
• Email: cklee[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 416
• Est. completion date: February 28, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peptic Ulcer
• Ulcer

Intervention

Drug:
• DWP14012 20mg
DWP14012 20mg, tablet, orally, once daily for up to 24 weeks
• Lansoprazole 15 mg
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
• DWP14012 20mg placebo
DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
• Lansoprazole 15 mg placebo
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator		at 24 weeks
Secondary	Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator		at 12 weeks
Secondary	Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24		at 12, 24 weeks