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

NCT ID: NCT03967886

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2020-05-27

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).

Conditions

Non-erosive Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

YYD601 20mg

Esomeprazole magnesium Dihydrate.

Group Type: EXPERIMENTAL

YYD601 20mg

Intervention Type: DRUG

Patients should take drugs an hour before breakfast.

Placebos

Intervention Type: DRUG

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.

Nexium 20mg

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Group Type: ACTIVE_COMPARATOR

Nexium 20mg

Intervention Type: DRUG

Patients should take drugs an hour before breakfast.

Placebos

Intervention Type: DRUG

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.

Interventions

YYD601 20mg

Patients should take drugs an hour before breakfast.

Intervention Type: DRUG

Nexium 20mg

Patients should take drugs an hour before breakfast.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Ansan Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YYPCT_YYD601_P3(2)

Identifier Type: -

Identifier Source: org_study_id