NCT03943992

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

A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Yooyoung Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-29
• Primary completion: 2020-01-31
• Completion: 2020-07-01
• First posted: 2019-05-09
• Last updated: 2021-05-11

Locations

1 site across 1 country: South Korea