Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

Phase 3

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: Nexium 40mg; Drug: YYD601 40mg; Drug: Placebos

• Registration Number: NCT03943992
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Primary Completion: 2020-01-31
• Study Completion: 2020-07-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

  1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
  2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexium 40mg	Nexium 40mg	Esomeprazole magnesium trihydrate, a substituted benzimidazole.
YYD601 40mg	YYD601 40mg	Esomeprazole magnesium Dihydrate.
YYD601 40mg	Placebos	Esomeprazole magnesium Dihydrate.
Nexium 40mg	Placebos	Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Primary Outcome Measures

Name	Time	Method
LA grade 0(zero)	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 Outcome Measures

Name	Time	Method
Frequency variation of the Heartburn in daytime by patients diary	at 4 week and 8 week from baseline	Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
LA grade 0(zero)	at 4 weeks	Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test.
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation	at week 4 and 8 from baseline	Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).	at week 4 and 8 from baseline	Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test.
Frequency variation of the Heartburn in nighttime by patients diary	at 4 week and 8 week from baseline	Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.

Trial Locations

Locations (1)

Korea University Ansan Hospital; 🇰🇷 Seoul, Korea, Republic of