Treatment Effect According to Timing of Administration of DWP14012 40 mg

NCT04613895 — Not applicable, Unknown, 186 participants, Daewoong Pharmaceutical Co. LTD.

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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

RegistryNCT04613895
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment186 (Estimated)
SponsorDaewoong Pharmaceutical Co. LTD. (Industry); collaborators: Hanyang University
ConditionsErosive Esophagitis
InterventionsDWP14012 (Drug)
Datesstart 2020-11-17 (estimated), primary completion 2021-05-30 (estimated), completion 2021-12-30 (estimated), first posted 2020-11-03, last updated 2020-11-03
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Erosive Esophagitis All trials of DWP14012

-Summary

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

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

+Arms and interventions

ArmTypeInterventionsDescription
fed state groupExperimentalDrug: DWP14012just after a meal
fasted state groupExperimentalDrug: DWP14012before a meal
  • DWP14012 (Drug), also known as fed state: DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
  • DWP14012 (Drug), also known as fasted state: DWP14012 40 mg, orally, once daily before a meal up to 4 weeks

+Outcome measures

Primary outcomes

  • healing rate at 4 week [4 week]: Cumulative healing rate of erosive esophagitis at 4 week by endoscopy

Secondary outcomes

  • healing rate at 2 week [2 week]: Cumulative healing rate of erosive esophagitis at 2 week by endoscopy

+Eligibility

Sex: All, ages: 19 Years to 75 Years

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

+Locations (1)

FacilityCityCountryStatus
Hanyang University Medical CenterSeoulSouth Korea