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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860624
• Other study ID #: Livzon-IY-81149R-11-01
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2016
• Last updated: August 8, 2016
• Start date: December 2011

Study information

• Verified date: July 2016
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• 10 mg ilaprazole
Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks
• 40mg esomeprazole
One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.		week 8	No