Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Livzon Pharmaceutical Group Inc.
• Treatments: Esomeprazole

Criteria

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.