Erosive Esophagitis
Conditions
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.
Interventions
DRUGYYD601 40mg
Patients should take druges 30 minutes before breakfast.
DRUGNexium 40mg
Patients should take druges 30 minutes before breakfast.
DRUGPlacebos
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.
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed