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NCT04888819 Clinical Trial

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: Recruiting

Administrative data
NCT number NCT04888819
Other study ID # IIT_DWP14012001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2021

Study information
Verified date May 2021
Source Konkuk University Medical Center
Contact Sun Na
Phone 82-2-2030-5027
Email 20190671@kuh.ac.kr
Is FDA regulated No
Health authority
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.

Recruitment information / eligibility
Status Recruiting
Enrollment 186
Est. completion date December 31, 2021
Est. primary completion date July 31, 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

Study Design

Related Conditions & MeSH terms

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 Konkuk University Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Konkuk University Medical Center Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary healing rate at week 4 Cumulative healing rate of erosive esophagitis at week 4 by endoscopy up to 4 weeks
See also
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Completed NCT04124926 - Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis Phase 3
Completed NCT01459367 - Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis Phase 3
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Completed NCT01499368 - A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients Phase 3
Not yet recruiting NCT04613895 - Treatment Effect According to Timing of Administration of DWP14012 40 mg N/A
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Completed NCT02028663 - Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis Phase 2
Completed NCT03006874 - Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis Phase 3
Completed NCT02388724 - Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis Phase 3
Completed NCT01865825 - Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)? N/A
Completed NCT02679508 - Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety Phase 4
Recruiting NCT06391177 - A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily Phase 1
Completed NCT05050188 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008 Phase 1
Completed NCT01874535 - Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy Phase 4
Completed NCT00206180 - NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Phase 4
Completed NCT01630746 - A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis Phase 3
Completed NCT01642615 - Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents Phase 2