Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

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/A

Clinical Study ID

NCT03943992
YYPCT_YYD601_P3
  • Ages 20-70
  • All Genders

Study 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).

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.
  1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above theweakness.
  2. 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

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.

Connect with a study center

  • Korea University Ansan Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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