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

NCT03943992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2021-05-11

No results posted yet for this study

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

Interventions

DRUG

YYD601 40mg

Patients should take druges 30 minutes before breakfast.

DRUG

Nexium 40mg

Patients should take druges 30 minutes before breakfast.

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.

Sponsors & Collaborators

  • Yooyoung Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-01-31
Completion
2020-07-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943992 on ClinicalTrials.gov