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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04341428

Collaborator

(none)

406

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

22.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healed Erosive Esophagitis	Drug: DWP14012 20 mg Drug: DWP14012 20 mg placebo Drug: Lansoprazole 15 mg Drug: Lansoprazole 15 mg Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 2, 2020

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: DWP14012 20mg

Orally, once daily

Drug: DWP14012 20 mg

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

Drug: Lansoprazole 15 mg Placebo

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

Active Comparator: Lansoprazole 15mg

Orally, once daily

Drug: DWP14012 20 mg placebo

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

Drug: Lansoprazole 15 mg

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

Outcome Measures

Primary Outcome Measures

Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 [at 24 week]

Secondary Outcome Measures

Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12 [at 12 week]

Other Outcome Measures

GERD-Health related quality life(HRQL) [at Weeks 4, 12, and 24]
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)
Assessment on symptoms [Weeks 4, 12, and 24]
Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
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:

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
Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
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 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)
Subjects who cannot stop the existing erosive esophagitis treatment being taken

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Yeouido ST. Mary's Hospital	Seoul		Korea, Republic of	07345

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:

NCT04341428

Other Study ID Numbers:

DW_DWP14012303

First Posted:

Apr 10, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Jul 1, 2020

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

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

Additional relevant MeSH terms:

Esophagitis

Lansoprazole

Dexlansoprazole

Study Results

No Results Posted as of Sep 3, 2020