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

Phase 3

Completed

• Conditions: Non-erosive Reflux Disease
• Interventions: Drug: Nexium 20mg; Drug: YYD601 20mg; Drug: Placebos

• Registration Number: NCT03967886
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Primary Completion: 2019-12-20
• Study Completion: 2020-05-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexium 20mg	Nexium 20mg	Esomeprazole magnesium trihydrate, a substituted benzimidazole.
YYD601 20mg	Placebos	Esomeprazole magnesium Dihydrate.
YYD601 20mg	YYD601 20mg	Esomeprazole magnesium Dihydrate.
Nexium 20mg	Placebos	Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Primary Outcome Measures

Name	Time	Method
Recovered percentage(%) of the symptom	within 4 weeks	Recovered percentage(%) of 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).
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 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).

Trial Locations

Locations (1)

Korea University Ansan Hospital; 🇰🇷 Seoul, Korea, Republic of