Treatment Effect According to Timing of Administration of DWP14012 40 mg

Erosive Esophagitis Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial Summary

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

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

• NCT number: NCT04613895
• Study type: Interventional
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: HOJIN LEE
• Phone: +82-2-550-8651
• Email: hjlee200@daewoong.co.kr
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 17, 2020
• Completion date: December 30, 2021