Treatment Effect According to Timing of Administration of DWP14012 40 mg

A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04613895

Enrollment

186

Registered

2020-11-03

Start date

2020-11-17

Completion date

2021-12-30

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis

Brief summary

The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Detailed description

Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.

Interventions

DRUGDWP14012

DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adults between 19 and 75 years old based on the date of written agreement * Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy * Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion criteria

* Those who have undergone gastric acid suppression or gastric, esophageal surgery * Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Design outcomes

Primary

Measure	Time frame	Description
healing rate at 4 week	4 week	Cumulative healing rate of erosive esophagitis at 4 week by endoscopy

Secondary

Measure	Time frame	Description
healing rate at 2 week	2 week	Cumulative healing rate of erosive esophagitis at 2 week by endoscopy

Countries

South Korea

Contacts

Primary ContactHOJIN LEE

hjlee200@daewoong.co.kr+82-2-550-8651

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026