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

Non-erosive Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967886
• Other study ID #: YYPCT_YYD601_P3(2)
• Status: Completed
• Phase: Phase 3
• Start date: April 10, 2019
• Est. completion date: May 27, 2020

Study information

• Verified date: May 2021
• Source: Yooyoung Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: May 27, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• YYD601 20mg
Patients should take drugs an hour before breakfast.
• Nexium 20mg
Patients should take drugs an hour before breakfast.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovered percentage(%) of the symptom	Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).	within 4 weeks
Primary	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
Primary	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
Primary	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
Primary	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