NCT04341428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 3, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

April 9, 2020

Last Update Submit

September 1, 2020

Conditions

Healed Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24

    at 24 week

Secondary Outcomes (1)

  • Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12

    at 12 week

Other Outcomes (2)

  • GERD-Health related quality life(HRQL)

    at Weeks 4, 12, and 24

  • Assessment on symptoms

    Weeks 4, 12, and 24

Study Arms (2)

DWP14012 20mg

EXPERIMENTAL

Orally, once daily

Drug: DWP14012 20 mgDrug: Lansoprazole 15 mg Placebo

Lansoprazole 15mg

ACTIVE COMPARATOR

Orally, once daily

Drug: DWP14012 20 mg placeboDrug: Lansoprazole 15 mg

Interventions

DWP14012 20 mgDRUG

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

DWP14012 20mg
DWP14012 20 mg placeboDRUG

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

Lansoprazole 15mg
Lansoprazole 15 mgDRUG

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

Lansoprazole 15mg
Lansoprazole 15 mg PlaceboDRUG

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

DWP14012 20mg

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, 07345, South Korea

RECRUITING

MeSH Terms

Interventions

fexuprazanLansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Oh-Young Lee

CONTACT

82-2-2290-8637leeoy@hanyang.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 10, 2020

Study Start

July 2, 2020

Primary Completion

August 30, 2021

Study Completion

December 30, 2021

Last Updated

September 3, 2020

Record last verified: 2020-07

Locations

KR(1)