Gastroesophageal Reflux Disease
Conditions
Keywords
GERD
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.
Interventions
DRUG10 mg ilaprazole
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
DRUG15 mg ilaprazole
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
DRUG40 mg esomeprazole
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
Sponsors
Livzon Pharmaceutical Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with healed esophagitis at week 8 | week 8 |
Secondary
| Measure | Time frame |
|---|---|
| resolution of clinical symptoms | week 8 |
| the proportion of patients healed at week 4 | week 4 |
Contacts
Primary ContactHaitang Hu, MD
Outcome results
None listed