Treatment Effect According to Timing of Administration of DWP14012 40 mg

Not Applicable

• Conditions: Erosive Esophagitis
• Interventions: Drug: DWP14012

• Registration Number: NCT04613895
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Last Update Submitted: 2020-10-28
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Study Start: 2020-11-17
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fed state group	DWP14012	just after a meal
fasted state group	DWP14012	before a meal

Primary Outcome Measures

Name	Time	Method
healing rate at 4 week	4 week	Cumulative healing rate of erosive esophagitis at 4 week by endoscopy

Secondary Outcome Measures

Name	Time	Method
healing rate at 2 week	2 week	Cumulative healing rate of erosive esophagitis at 2 week by endoscopy

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of