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

Launched by LIVZON PHARMACEUTICAL GROUP INC. · Aug 8, 2016

Keywords

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Gender

ALL

Eligibility 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.