Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471094

Enrollment

831

Registered

2007-05-09

Start date

2007-05-31

Completion date

2007-10-31

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis

Keywords

heartburn, erosive esophagitis, healing, population pharmacokinetics, Quality of Life (QoL)

Brief summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Detailed description

This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.

Interventions

DRUGIlaprazole

Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.

DRUGLansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion criteria

* Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condition likely to require surgery; cancer within 5 years of screening; or abnormal laboratory values. * Co-existing diseases affecting the esophagus; history of esophageal radiation therapy, cryotherapy, or physiochemical trauma. * History of esophageal surgery or dilatation of an esophageal stricture other than Schatzki's ring; gastric or duodenal surgery except simple oversew of an ulcer. * Active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening. * Current or history of Zollinger-Ellison syndrome or other hypersecretory conditions. * Allergy to any proton pump inhibitor drug (omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole), any component of Ilaprazole, or antacid. * Unable to tolerate lactose. * Use of the following medications prior to randomization or anticipated use during the study: proton pump inhibitors, antacids, biphosphonates, histamine (H2) receptor antagonist (examples: Zantac, Tagamet), sucralfate, misoprostol, corticosteroids, prokinetics, Non-steroidal anti-inflammatory drugs (NSAIDs), strong anticholinergics, anticoagulant/anti-platelet aggregate therapy, anticoagulants, digoxin, theophylline, phenytoin. * History of alcoholism or drug addiction.

Design outcomes

Primary

Measure	Time frame
The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.	Week 4

Secondary

Measure	Time frame
The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.	Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026