Efficacy of DA-5204 on Gastroesophageal Reflux Disease

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StatusAfsluttet

Sponsorer

Seoul National University Hospital

Samarbejdspartnere

Dong-A ST Co., Ltd.

KLINISK FORSØG: NCT03998969

BioSeek: NCT03998969

Nøgleord

Abstrakt

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.

Beskrivelse

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).

Datoer

Sidst bekræftet:	05/31/2019
Først indsendt:	06/24/2019
Anslået tilmelding indsendt:	06/24/2019
Først indsendt:	06/25/2019
Sidste opdatering indsendt:	06/24/2019
Sidste opdatering indsendt:	06/25/2019
Faktisk startdato for undersøgelsen:	05/31/2016
Anslået primær afslutningsdato:	12/10/2018
Anslået afslutningsdato for undersøgelsen:	12/10/2018

Tilstand eller sygdom

Esophageal Disease

Intervention / behandling

Drug: Pantoprazole

Drug: Pantoprazole and DA-5204

Drug: Pantoprazole and placebo

Fase

Fase 3

Armgrupper

Arm	Intervention / behandling
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

Kriterier for støtteberettigelse

Alder berettiget til undersøgelse	20 Years Til 20 Years
Køn, der er berettiget til undersøgelse	All
Accepterer sunde frivillige	Ja
Kriterier	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

Primære resultatforanstaltninger

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.

Sekundære resultatforanstaltninger

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

Nøgleord

heartburn

ulcer

gastroøsofagal refluksygdom

oesophagitis

gastritis

mavesår

bynke

artemisia indica

antioxidant