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Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)

NCT00953381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2009-08-06

No results posted yet for this study

Summary

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 mg/day as positive control. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.

Conditions

  • Duodenal Ulcer

Interventions

DRUG

5 mg ilaprazole

One 5-mg ilaprazole tablet (Livzon Pharm Group Inc., China) together with three placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks

DRUG

10 mg ilaprazole

Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with two placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks

DRUG

20 mg ilaprazole

Four 5-mg ilaprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks

DRUG

20 mg omeprazole

One 20-mg omeprazole capsule (AstraZeneca, Losec) together with four placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Principal Investigators

  • S R Lin, M.D · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-03-31
Completion
2005-05-31

Countries

  • China

Study Locations

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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 NCT00953381 on ClinicalTrials.gov