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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: 10 mg ilaprazole
* Drug: 15 mg ilaprazole
* Drug: 40 mg esomeprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg ilaprazole<br> | Drug: 10 mg ilaprazole<br>* Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks<br>|
| Experimental: 15 mg ilaprazole<br> | Drug: 15 mg ilaprazole<br>* Three 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks<br>|
| Active Comparator: 40 mg esomeprazole<br> | Drug: 40 mg esomeprazole<br>* One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package being taken orally each morning on an empty stomach for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with healed esophagitis at week 8 |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients healed at week 4 |  | week 4 | 
| resolution of clinical symptoms |  | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD