Clinical Trials/NCT03943992

NCT03943992

Completed

Phase 3

A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).

Yooyoung Pharmaceutical Co., Ltd.1 site in 1 country170 target enrollmentJanuary 29, 2019

ConditionsErosive Esophagitis

InterventionsYYD601 40mg Placebos Nexium 40mg

DrugsYYD601 40mg Nexium 40mg Placebos

Overview

Phase: Phase 3
Intervention: YYD601 40mg
Conditions: Erosive Esophagitis
Sponsor: Yooyoung Pharmaceutical Co., Ltd.
Enrollment: 170
Locations: 1
Primary Endpoint: LA grade 0(zero)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).

Detailed Description

This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.

Registry

clinicaltrials.gov

Start Date

January 29, 2019

End Date

July 1, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A man or woman over 20 years old less than 70 years old.
•A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A\~D) measured through the endoscopy which is carried out within (-2W±D2)
•\* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
•Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
•Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
•A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.

Exclusion Criteria

•Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
•Who has NERD
•Who get a diagnosis as a IBS within the last 3 months.
•Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
•Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (\* refer to the Concomitant medication in text.)
•Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
•Who has clinically significant abnormal result of ECG.
•Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
•Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.

Arms & Interventions

YYD601 40mg

Esomeprazole magnesium Dihydrate.

Intervention: YYD601 40mg

YYD601 40mg

Esomeprazole magnesium Dihydrate.

Intervention: Placebos

Nexium 40mg

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Intervention: Nexium 40mg

Nexium 40mg

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Intervention: Placebos

Outcomes

Primary Outcomes

LA grade 0(zero)

Time Frame: within 8 weeks

Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.

Secondary Outcomes

Frequency variation of the Heartburn in daytime by patients diary(at 4 week and 8 week from baseline)
LA grade 0(zero)(at 4 weeks)
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation(at week 4 and 8 from baseline)
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).(at week 4 and 8 from baseline)
Frequency variation of the Heartburn in nighttime by patients diary(at 4 week and 8 week from baseline)