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

Erosive Esophagitis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943992
• Other study ID #: YYPCT_YYD601_P3
• Status: Completed
• Phase: Phase 3
• Start date: January 29, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2021
• Source: Yooyoung Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis
• Gastroesophageal Reflux

Intervention

Drug:
• YYD601 40mg
Patients should take druges 30 minutes before breakfast.
• Nexium 40mg
Patients should take druges 30 minutes before breakfast.
• Placebos
The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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