Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Drug: 10 mg ilaprazole
- Registration Number
- NCT02860624
- Lead Sponsor
- Livzon Pharmaceutical Group Inc.
- Brief Summary
This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
- Consenting patients will be eligible for enrollment if they:
- are 18-70 years of age,
- have at least one of the two symptoms, heartburn and reflux,
- have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.
Exclusion Criteria
- Patients will be ineligible if they:
- have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
- have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
- have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
- participated in a clinical trial with an investigational drug or device within the past three months,
- have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
- have alcoholic intemperance, drug addiction or any other improper habits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 mg esomeprazole 40mg esomeprazole - 10 mg ilaprazole 10 mg ilaprazole -
- Primary Outcome Measures
Name Time Method Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels. week 8
- Secondary Outcome Measures
Name Time Method