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

YooYoung Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Non-erosive Reflux Disease

Treatments: Drug: YYD601 20mg; Drug: Placebos; Drug: Nexium 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03967886

YYPCT_YYD601_P3(2)

Details and patient eligibility

About

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

Full 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).

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 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.

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 20mg

Experimental group

Description:

Esomeprazole magnesium Dihydrate.

Treatment:

Drug: Placebos

Drug: YYD601 20mg

Nexium 20mg

Active Comparator group

Description:

Esomeprazole magnesium trihydrate, a substituted benzimidazole.

Treatment:

Drug: Placebos

Drug: Nexium 20mg