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

NCT03967886 | Completed Phase 3 DMC

• 1 other identifier: YYPCT_YYD601_P3(2)
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-erosive Reflux Disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

YYD601 20mg

EXPERIMENTAL

Esomeprazole magnesium Dihydrate.

Drug: YYD601 20mg; Drug: Placebos

Nexium 20mg

ACTIVE COMPARATOR

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Drug: Nexium 20mg; Drug: Placebos

Interventions

YYD601 20mg DRUG

Patients should take drugs an hour before breakfast.

YYD601 20mg

Nexium 20mg DRUG

Patients should take drugs an hour before breakfast.

Nexium 20mg

Placebos 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; YYD601 20mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Korea University Ansan Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: April 10, 2019
• Primary Completion: December 20, 2019
• Study Completion: May 27, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

KR (1)