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EsophagitisPhase 2NCT00471094

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 testing Ilaprazole and Lansoprazole in people with Esophagitis, run by Takeda at 94 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagitis
What is being tested?
Ilaprazole and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
831 participants
Where
94 sitesUnited States
Study dates
May 2007to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Beaumont, Texas

  • Study site

    Beaver Falls, Pennsylvania

  • Study site

    Binghamton, New York

  • Study site

    Boise, Idaho

  • Study site

    Bristol, Connecticut

  • Study site

    Bristol, Tennessee

  • Study site

    Bryan, Texas

  • Study site

    Chandler, Arizona

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chevy Chase, Maryland

  • Study site

    Cincinnati, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colorado Springs, Colorado

  • Study site

    Conyers, Georgia

  • Study site

    Cypress, California

  • Study site

    Davenport, Iowa

  • Study site

    Dayton, Ohio

  • Study site

    Dubuque, Iowa

  • Study site

    Egg Harbor, New Jersey

  • Study site

    El Paso, Texas

  • Study site

    Encinitas, California

  • Study site

    Fayetteville, North Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Garden Grove, California

  • Study site

    Goose Creek, South Carolina

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Harrisburg, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Hueytown, Alabama

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Kansas City, Missouri

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Longmont, Colorado

  • Study site

    Longwood, Florida

  • Study site

    Medford, Oregon

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Miami, Florida

  • Study site

    Midvale, Utah

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mission Hills, California

  • Study site

    Moline, Illinois

  • Study site

    Monroe, Wisconsin

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Newnan, Georgia

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • Study site

    Norman, Oklahoma

  • Study site

    Oakland, California

  • Study site

    Odessa, Texas

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orange, California

  • Study site

    Pasadena, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Pueblo, Colorado

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sherwood, Arkansas

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spokane, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Tucker, Georgia

  • Study site

    Tucson, Arizona

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Covina, California

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Esophagitis
Being tested
Ilaprazole, Lansoprazole
Keywords
heartburn, erosive esophagitis, healing, population pharmacokinetics, Quality of Life (QoL)
Medical subject headings
Esophagitis, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IlaprazoleDrug

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

  • IlaprazoleDrug

    Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.

  • IlaprazoleDrug

    Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.

  • LansoprazoleDrug

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

Study groups in NCT00471094
Study groupRoleWhat they receive
Ilaprazole 5 mg QDExperimentalNot described
Receives: Drug: Ilaprazole
Ilaprazole 20 mg QDExperimentalNot described
Receives: Drug: Ilaprazole
Ilaprazole 40 mg QDExperimentalNot described
Receives: Drug: Ilaprazole
Lansoprazole 30 mg QDActive comparatorNot described
Receives: Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.

    Measured: Week 4

Secondary outcomes (1)

  1. The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
831 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00471094
Sponsor's protocol ID
Z-EE05-123
Other IDs
U1111-1127-6202
Status last verified
Jan 2012
First submitted
7 May 2007
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ilaprazole and Lansoprazole in people with Esophagitis, run by Takeda at 94 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00471094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.

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