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

NCT ID: NCT02860624

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg ilaprazole

Group Type: EXPERIMENTAL

10 mg ilaprazole

Intervention Type: DRUG

Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks

40 mg esomeprazole

Group Type: ACTIVE_COMPARATOR

40mg esomeprazole

Intervention Type: DRUG

One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks

Interventions

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

Intervention Type: DRUG

40mg esomeprazole

One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Livzon Pharmaceutical Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.

Reference Type: DERIVED

PMID: 29540336 (View on PubMed)

Other Identifiers

Livzon-IY-81149R-11-01

Identifier Type: -

Identifier Source: org_study_id