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

YooYoung Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Erosive Esophagitis

Treatments: Drug: YYD601 40mg; Drug: Nexium 40mg; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT03943992

YYPCT_YYD601_P3

Details and patient eligibility

About

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).

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

  1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
  2. 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

YYD601 40mg

Experimental group

Description:

Esomeprazole magnesium Dihydrate.

Treatment:

Drug: Placebos

Drug: YYD601 40mg

Nexium 40mg

Active Comparator group

Description:

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Treatment:

Drug: Nexium 40mg

Drug: Placebos