Efficacy of DA-5204 on Gastroesophageal Reflux Disease

NCT03998969 | Completed Phase 3

• 1 other identifier: SNUBH-DHLDA5204
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.

Conditions

Esophageal Disease

Keywords

Gastroesophageal Reflux; Esophagitis, Peptic

Outcome Measures

Primary Outcomes (2)

• Endoscopically effective improvement

  A percentage of subjects showed effective improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "effective improvement" is the subjects showed score changed from 3 to 0, from 2 to 0, or from 3 to 1. \[score 0(LA grade N): normal mucosa, score 1(LA grade M): minimal changes to the mucosa such as erythema, blurring and/or whitish turbidity, score 2(LA grade A): non-confluent mucosal breaks \<5 mm in length, score 3(LA grade B): non-confluent mucosal breaks ≥5 mm in length\]

  4 weeks

• Endoscopically complete improvement

  A percentage of subjects showed complete improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "complete improvement" is the subjects showed score changed from 3 to 0 or from 2 to 0.

  4 weeks

Secondary Outcomes (1)

• Symptom improvement

  4 weeks

Study Arms (2)

Pantoprazole and DA-5204

EXPERIMENTAL

Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks

Drug: Pantoprazole; Drug: DA-5204

Pantoprazole and placebo

ACTIVE COMPARATOR

Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks

Drug: Pantoprazole; Drug: Placebo

Interventions

Pantoprazole DRUG

Pantoprazole 40mg tablet

Also known as: Pantoline

Pantoprazole and DA-5204; Pantoprazole and placebo

DA-5204 DRUG

DA-5204 tablet

Also known as: Stillen 2X®

Pantoprazole and DA-5204

Placebo DRUG

Film-coated tablet manufactured to mimic DA-5204

Also known as: Placebo (for DA-5204)

Pantoprazole and placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is over 20 years old, under 75 years old, men or women
• Patients diagnosed with erosive esophagitis by gastroscopy
• Signed the informed consent forms

You may not qualify if:

• Patients who is impossible to receive gastroscopy
• Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
• Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
• Patients with surgery related to gastroesophageal
• Patients with Zollinger-Ellison syndrome
• Patients with any kind of malignant tumor
• Patients administered with anti-thrombotic drugs
• Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
• Patients with neuropsychiatric disorder, alcoholism, or drug abuse
• Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
• Women either pregnant or breast feeding

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Bungdang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Esophageal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic

Interventions

Pantoprazole; DA-5204

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong Ho Lee, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 26, 2019
• Study Start: June 1, 2016
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)