Last updated: May 7, 2021
Sponsor: Yooyoung Pharmaceutical Co., Ltd.
Overall Status: Completed
Phase
3
Condition
Esophageal Disorders
Heartburn (Pediatric)
Gastroesophageal Reflux Disease (Gerd)
Treatment
N/AClinical Study ID
NCT03943992
YYPCT_YYD601_P3
Ages 20-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 7days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis asErosive esophagitis(LA grade A~D) measured through the endoscopy which is carried outwithin (-2W±D2)
- Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
- Experienced above 2 days in 1 week, Heartburn of acid regurgitation above theweakness.
- Experienced above 1 day in 1 week, Heartburn of acid regurgitation above themiddle.
- A man or woman who has a full understanding of this clinical trial through thedetailed explanation, agree in writing to participate in this trial.
Exclusion
Exclusion Criteria:
- Who has hyper sensitivity reaction about other drugs, ingredients, components ofinvestigator 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 beforethe 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 ahistory 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'sesophagus.
Study Design
Total Participants: 170
Study Start date:
January 29, 2019
Estimated Completion Date:
July 01, 2020
Study Description
Connect with a study center
Korea University Ansan Hospital
Seoul,
Korea, Republic ofSite Not Available
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