Efficacy of DA-5204 on Gastroesophageal Reflux Disease

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Patrocinadors

Seoul National University Hospital

Col·laboradors

Dong-A ST Co., Ltd.

ASSAIG CLÍNIC: NCT03998969

BioSeek: NCT03998969

Paraules clau

malaltia per reflux gastroesofàgic

Resum

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.

Descripció

Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation.

Proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have insufficient effect on this therapy alone.

DA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux esophagitis (esophageal mucosal injury).

Dates

Darrera verificació:	05/31/2019
Primer enviat:	06/24/2019
Inscripció estimada enviada:	06/24/2019
Publicat per primera vegada:	06/25/2019
Última actualització enviada:	06/24/2019
Publicació de l'última actualització:	06/25/2019
Data d'inici de l'estudi real:	05/31/2016
Data estimada de finalització primària:	12/10/2018
Data estimada de finalització de l’estudi:	12/10/2018

Condició o malaltia

Esophageal Disease

Intervenció / tractament

Drug: Pantoprazole

Drug: Pantoprazole and DA-5204

Drug: Pantoprazole and placebo

Fase

Fase 3

Grups de braços

Braç	Intervenció / tractament
Experimental: Pantoprazole and DA-5204 Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks	Drug: Pantoprazole and DA-5204 DA-5204 tablet
Active Comparator: Pantoprazole and placebo Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks	Drug: Pantoprazole and placebo Film-coated tablet manufactured to mimic DA-5204

Criteris d'elegibilitat

Edats elegibles per estudiar	20 Years Per a 20 Years
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	Inclusion Criteria: - 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 Exclusion Criteria: - 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

Resultat

Mesures de resultats primaris

1. Endoscopically effective improvement [4 weeks]

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]

2. Endoscopically complete improvement [4 weeks]

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.

Mesures de resultats secundaris

1. Symptom improvement [4 weeks]

A percentage of subjects showed sufficient improvement of reflux symptom score from Gastroesophageal Reflux Disease Questionnaire (GerdQ). The definition of "sufficient improvement" is the subjects showed ≥50% reduction from the initial sum of scores for GerdQ.

Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Paraules clau

pirosi

ulcer

malaltia per reflux gastroesofàgic

esofagitis

gastritis

úlcera pèptica

artemísia

artemisia indica

antioxidant