NCT04613895

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	DWP14012	DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
DRUG	DWP14012	DWP14012 40 mg, orally, once daily before a meal up to 4 weeks

Timeline

• Start date: 2020-11-17
• Primary completion: 2021-05-30
• Completion: 2021-12-30
• First posted: 2020-11-03
• Last updated: 2020-11-03

Locations

1 site across 1 country: South Korea