Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Healed Erosive Esophagitis Clinical Trial

Official title:

A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341428
• Other study ID #: DW_DWP14012303
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Oh-Young Lee
• Phone: 82-2-2290-8637
• Email: leeoy[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: December 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed

2. Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)

3. Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis

Exclusion Criteria:

1. Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening

2. Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.

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 must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)

6. Subjects who cannot stop the existing erosive esophagitis treatment being taken

Related Conditions & MeSH terms

• Esophagitis
• Healed Erosive Esophagitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Yeouido ST. Mary's Hospital	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
Other	GERD-Health related quality life(HRQL)	Changes from baseline in the total score of GERD-HRQL at Weeks 4, 12, and 24(The total score could range from 0 to 50 and lower score was evaluated as higher quality of life)	at Weeks 4, 12, and 24
Other	Assessment on symptoms	Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24	Weeks 4, 12, and 24
Primary	Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24		at 24 week
Secondary	Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12		at 12 week