Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

• Status: Completed
• Trial end date: 2020-05-27
• Target enrollment: 0
• Participant gender: All

Summary

Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.
• Treatments: Esomeprazole

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.

1. A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.

2. 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.

3. 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 (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 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.