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

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

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 Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: 10 mg ilaprazole; Drug: 15 mg ilaprazole; Drug: 40 mg esomeprazole

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg ilaprazole	Drug: 10 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
Experimental: 15 mg ilaprazole	Drug: 15 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
Active Comparator: 40 mg esomeprazole	Drug: 40 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Livzon Pharmaceutical Group Inc.
• Investigators: Principal Investigator: Sanren Lin, MD, Peking University Third Hospital; Principal Investigator: Liya Zhou, MD, Peking University Third Hospital

Publications and helpful links

General Publications

• Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig. 2016 Dec;36(12):985-992. doi: 10.1007/s40261-016-0446-3.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): April 21, 2010
• Last Update Submitted That Met QC Criteria: April 20, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: GERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: Livzon-IY-81149R-09; SFDA2004L00137