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

January 31, 2012 updated by: Takeda

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

831

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hueytown, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Phoenix, Arizona, United States
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Sherwood, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Cypress, California, United States
      • Encinitas, California, United States
      • Garden Grove, California, United States
      • Irvine, California, United States
      • Lancaster, California, United States
      • Mission Hills, California, United States
      • Oakland, California, United States
      • Orange, California, United States
      • Pasadena, California, United States
      • San Diego, California, United States
      • West Covina, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Longmont, Colorado, United States
      • Pueblo, Colorado, United States
    • Connecticut
      • Bristol, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Longwood, Florida, United States
      • Miami, Florida, United States
      • New Smyrna Beach, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
      • Zephyrhills, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Conyers, Georgia, United States
      • Newnan, Georgia, United States
      • Tucker, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Moline, Illinois, United States
      • Rockford, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
      • Davenport, Iowa, United States
      • Dubuque, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Chevy Chase, Maryland, United States
      • Prince Frederick, Maryland, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • Kansas City, Missouri, United States
      • Mexico, Missouri, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Binghamton, New York, United States
      • Great Neck, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Fayetteville, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Dayton, Ohio, United States
    • Oklahoma
      • Norman, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States
      • Harrisburg, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Goose Creek, South Carolina, United States
      • Mt. Pleasant, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Bryan, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Odessa, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Midvale, Utah, United States
      • Ogden, Utah, United States
    • Virginia
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Monroe, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lansoprazole 30 mg QD
Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 5 mg QD
Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 20 mg QD
Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 40 mg QD
Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 9, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-EE05-123
  • U1111-1127-6202 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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