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

Phase 2

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: 40 mg esomeprazole; Drug: 10 mg ilaprazole; Drug: 15 mg ilaprazole

• Registration Number: NCT01107938
• Lead Sponsor: Livzon Pharmaceutical Group Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-20
• Last Update Submitted: 2010-04-20
• Study First Posted: 2010-04-21
• Last Update Posted: 2010-04-21
• Study Start: 2010-05
• Primary Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 mg esomeprazole	40 mg esomeprazole	-
10 mg ilaprazole	10 mg ilaprazole	-
15 mg ilaprazole	15 mg ilaprazole	-

Primary Outcome Measures

Name	Time	Method
the proportion of patients with healed esophagitis at week 8	week 8

Secondary Outcome Measures

Name	Time	Method
the proportion of patients healed at week 4	week 4
resolution of clinical symptoms	week 8