None listed
Conditions
Interventions
Drug : The efficacy of Ilaprazole 10mg twice a day or Ilaprazole 20mg once a day therapy for 8 weeks in patient with refractory Gastroesophageal reflux diseases which was not improved by standard ther
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patient with refractory Gastroesophageal reflux disease who remained symptomatic in spite of standard therapy of current Proton Pump Inhibitor except Ilaprazole (2)Those who heard the explanation of this clinical trial and decided to voluntarily participate and signed the consent form
Exclusion criteria
Exclusion criteria: (1) Those with hypersensitivity to Proton pump inhibitor including Ilaprazole (2) Those who were not benefited from other Proton pump inhibitor administration for Gastroesophageal reflux disease due to low compliance. (3) Those with need to constantly take Steroids or Non steroidal anti inflammatory drugs including Aspirin (more than 325mg/d), Warfarin, Coumarin. (4) Those with Esophageal stricture, 3 cm of Barrett's esophagus, gastrointestinal bleeding, stomach and duodenal ulcer, Zollinger-Ellison syndrome, malignant tumor or other serious disease. (5) Those who had been treated with Helicobacter pylori eradication therapy within 6 months before participation of the clinical trial. (6) Those who has undergone gastric acid suppression surgery or gastro-duodenal surgery. (7) Those who has undergone major surgery affecting gastric acid secretion except surgery such as appendectomy, cholecystectomy, hysterectomy. (8) Current alcohol addictor or those with the history of drug abuse. (9) Pregnant and lactating women (10) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women) (11) Those who participated in other clinical trial within 30 days before Screening. (12) Those who are judged to be improper for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who have no day and night heartburn symptoms for the last 7 days at 4 and 8 weeks of Ilaprazole administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of A,B and C,D grade subjects according to Los Angeles grade who had no heartburn symptoms for the last 7 days on 4 and 8 weeks of Ilaprazole administration. | — |
Countries
Korea, Republic of
Contacts
Public Contacthanglak Lee
Hanyang University Seoul Hospital
Outcome results
None listed