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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04613895
• Other study ID #: IIT_DWP14012001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: HOJIN LEE
• Phone: +82-2-550-8651
• Email: hjlee200[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

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.

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 186
• Est. completion date: December 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• DWP14012
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
• DWP14012
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.	Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing rate at 4 week	Cumulative healing rate of erosive esophagitis at 4 week by endoscopy	4 week
Secondary	healing rate at 2 week	Cumulative healing rate of erosive esophagitis at 2 week by endoscopy	2 week