NCT01107938

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-06-01
• First posted: 2010-04-21
• Last updated: 2010-04-21