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

NCT01107938 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2010-04-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Principal Investigators

  • Sanren Lin, MD · Peking University Third Hospital

  • Liya Zhou, MD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107938 on ClinicalTrials.gov