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

Last updated: May 7, 2021
Sponsor: Yooyoung Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT03967886
YYPCT_YYD601_P3(2)
  • Ages 20-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 abovethe weakness.
  • Experienced above 1 day in a week, heartburn of acid regurgitation above themiddle.
  1. A man or woman who has been made diagnosis as LA grade0(Zero) measured throughthe dendoscopy which is corried out within 14 days, there is no observed muscosalbreak.
  • 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 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 beforethe 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 ahistory of radio therapeutics, freeze treatment about the esophagus.
  • Who has the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretorycondition 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 thisclinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.

Study Design

Total Participants: 170
Study Start date:
April 10, 2019
Estimated Completion Date:
May 27, 2020

Study 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).

Connect with a study center

  • Korea University Ansan Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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