Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
Study Details
Study Description
Brief Summary
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: YYD601 20mg Esomeprazole magnesium Dihydrate. |
Drug: YYD601 20mg
Patients should take drugs an hour 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 20mg Esomeprazole magnesium trihydrate, a substituted benzimidazole. |
Drug: Nexium 20mg
Patients should take drugs an hour 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
- Recovered percentage(%) of the symptom [within 4 weeks]
Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
- Change of the score about the symptom [within 4 weeks]
Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
- Percentage(%) of the patients who have symptom during the daytime [within 4 weeks]
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).
- Percentage(%) of the patients who have symptom during the nighttime [within 4 weeks]
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
- Percentage(%) of the days no symtom [within 4 weeks]
Percentage(%) of the days no symptom(heartburn or/and acid regurgitation) among the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A man or woman over 20 years old less than 70 years old.
-
A man or woman who has below all characters and diagnosis as NERD.
-
A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
-
A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria.
** Symptom (heartburn and acid regurgitation) is confirmed by RDQ
-
Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness.
-
Experienced above 1 day in a week, heartburn of acid regurgitation above the middle.
- A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break.
- 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 ERD.
-
Who get a diagnosis as a IBS within the last 3 months.
-
Who have taken drugs about reflux esophagitis (Hâ‚‚-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.)
-
Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
-
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 the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced.
-
Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole).
-
Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
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(2)