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

A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).

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

Study Overview

• Status: Completed
• Conditions: Non-erosive Reflux Disease
• Intervention / Treatment: Drug: Placebos; Drug: YYD601 20mg; Drug: Nexium 20mg

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Ansan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YYD601 20mg; Esomeprazole magnesium Dihydrate.	Drug: Placebos; The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.; Drug: YYD601 20mg; Patients should take drugs an hour before breakfast.
ACTIVE_COMPARATOR: Nexium 20mg; Esomeprazole magnesium trihydrate, a substituted benzimidazole.	Drug: Placebos; The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.; Drug: Nexium 20mg; Patients should take drugs an hour before breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovered percentage(%) of the symptom	Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).	within 4 weeks
Change of the score about the symptom	Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).	within 4 weeks
Percentage(%) of the patients who have symptom during the daytime	Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).	within 4 weeks
Percentage(%) of the patients who have symptom during the nighttime	Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).	within 4 weeks
Percentage(%) of the days no symtom	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).	within 4 weeks

Collaborators and Investigators

• Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): May 27, 2020

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: YYPCT_YYD601_P3(2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No