NCT01107938UnknownPhase 2
Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 330
- Primary Endpoint
- the proportion of patients with healed esophagitis at week 8
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
10 mg ilaprazole
Experimental
Intervention: 10 mg ilaprazole (Drug)
15 mg ilaprazole
Experimental
Intervention: 15 mg ilaprazole (Drug)
40 mg esomeprazole
Active Comparator
Intervention: 40 mg esomeprazole (Drug)
Outcomes
Primary Outcomes
the proportion of patients with healed esophagitis at week 8
Time Frame: week 8
Secondary Outcomes
- the proportion of patients healed at week 4(week 4)
- resolution of clinical symptoms(week 8)
Investigators
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