Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

NCT03943992 | Completed Phase 3 DMC

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

Brief Summary

A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• LA grade 0(zero)

  Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.

  within 8 weeks

Secondary Outcomes (5)

• LA grade 0(zero)

  at 4 weeks

• Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).

  at week 4 and 8 from baseline

• Frequency variation of the Heartburn in daytime by patients diary

  at 4 week and 8 week from baseline

• Frequency variation of the Heartburn in nighttime by patients diary

  at 4 week and 8 week from baseline

• Days percentage(%) of no symptoms about the Heartburn and acid regurgitation

  at week 4 and 8 from baseline

Study Arms (2)

YYD601 40mg

EXPERIMENTAL

Esomeprazole magnesium Dihydrate.

Drug: YYD601 40mg; Drug: Placebos

Nexium 40mg

ACTIVE COMPARATOR

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Drug: Nexium 40mg; Drug: Placebos

Interventions

YYD601 40mg DRUG

Patients should take druges 30 minutes before breakfast.

YYD601 40mg

Nexium 40mg DRUG

Patients should take druges 30 minutes before breakfast.

Nexium 40mg

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 40mg; YYD601 40mg

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 experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A\~D) measured through the endoscopy which is carried out within (-2W±D2)
• \* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
• Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
• Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
• 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 NERD
• Who get a diagnosis as a IBS within the last 3 months.
• Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
• 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 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 clinically significant abnormal result of ECG.
• Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
• Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Korea University Ansan Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Esomeprazole

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: March 25, 2019
• First Posted: May 9, 2019
• Study Start: January 29, 2019
• Primary Completion: January 31, 2020
• Study Completion: July 1, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

KR (1)