Treatment Effect According to Timing of Administration of DWP14012 40 mg

Daewoong Pharmaceutical

Status: Unknown

Conditions: Erosive Esophagitis

Treatments: Drug: DWP14012

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04613895

IIT_DWP14012001

Details and patient eligibility

About

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

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

Enrollment: 186 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

fed state group

Experimental group

Description:

just after a meal

Treatment:

Drug: DWP14012

Drug: DWP14012

fasted state group

Experimental group

Description:

before a meal

Treatment:

Drug: DWP14012

Drug: DWP14012