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Clinical Trials/NCT01107938
NCT01107938UnknownPhase 2

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

Livzon Pharmaceutical Group Inc.0 sites330 target enrollmentStarted: May 2010Last updated:
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

Sponsor Class
Industry

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