A Comparative study about the effectiveness of Ilprazole in refractory GERD according to dosing method
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003691
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 164
(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
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.