Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: YYD601 40mg Esomeprazole magnesium Dihydrate. |
Drug: YYD601 40mg
Patients should take druges 30 minutes before breakfast.
Drug: 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.
|
| Active Comparator: Nexium 40mg Esomeprazole magnesium trihydrate, a substituted benzimidazole. |
Drug: Nexium 40mg
Patients should take druges 30 minutes before breakfast.
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
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Who get a diagnosis as a IBS within the last 3 months.
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Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Ansan Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yooyoung Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YYPCT_YYD601_P3