Back to resultsClinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
Primary Purpose
Erosive Esophagitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YYD601 40mg
Nexium 40mg
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis
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.
Sites / Locations
- Korea University Ansan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
YYD601 40mg
Nexium 40mg
Arm Description
Esomeprazole magnesium Dihydrate.
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03943992
First Posted
March 25, 2019
Last Updated
May 7, 2021
Sponsor
Yooyoung Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03943992
Brief Title
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
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).
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yooyoung Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YYD601 40mg
Arm Type
Experimental
Arm Description
Esomeprazole magnesium Dihydrate.
Arm Title
Nexium 40mg
Arm Type
Active Comparator
Arm Description
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
Intervention Type
Drug
Intervention Name(s)
YYD601 40mg
Intervention Description
Patients should take druges 30 minutes before breakfast.
Intervention Type
Drug
Intervention Name(s)
Nexium 40mg
Intervention Description
Patients should take druges 30 minutes before breakfast.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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.
Primary Outcome Measure Information:
Title
LA grade 0(zero)
Description
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.
Time Frame
within 8 weeks
Secondary Outcome Measure Information:
Title
LA grade 0(zero)
Description
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test.
Time Frame
at 4 weeks
Title
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).
Description
Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test.
Time Frame
at week 4 and 8 from baseline
Title
Frequency variation of the Heartburn in daytime by patients diary
Description
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Time Frame
at 4 week and 8 week from baseline
Title
Frequency variation of the Heartburn in nighttime by patients diary
Description
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Time Frame
at 4 week and 8 week from baseline
Title
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation
Description
Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.
Time Frame
at week 4 and 8 from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
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