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Esophagitis, RefluxPhase 3NCT00255151

Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

A Phase 3 study testing Dexlansoprazole MR in people with Esophagitis, Reflux and Esophagitis, Peptic, run by Takeda at 100 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 ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagitis, Reflux, Esophagitis, Peptic
What is being tested?
Dexlansoprazole MR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
100 sitesUnited States
Study dates
Jan 2006to Nov 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Who cannot join

  • Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
  • Use of antacids (except for study supplied) throughout the study.
  • Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Need for continuous anticoagulant therapy.

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anderson, South Carolina

  • Study site

    Anniston, Alabama

  • Study site

    Atlanta, Georgia

  • Study site

    Azusa, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bellevue, Washington

  • Study site

    Bismarck, North Dakota

  • Study site

    Bristol, Connecticut

  • Study site

    Carmichael, California

  • Study site

    Champaign, Illinois

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chevy Chase, Maryland

  • Study site

    Columbus, Ohio

  • Study site

    Conroe, Texas

  • Study site

    Cypress, California

  • Study site

    Dallas, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Dayton, Ohio

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Evansville, Indiana

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Germantown, Tennessee

  • Study site

    Greensboro, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Hueytown, Alabama

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Mississippi

  • Study site

    Jackson, Tennessee

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Lakewood, Washington

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Longmont, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Missoula, Montana

  • Study site

    Modesto, California

  • Study site

    Mogadore, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Naples, Florida

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Newark, Delaware

  • Study site

    Newburgh, Indiana

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    North Chicago, Illinois

  • Study site

    North Little Rock, Arkansas

  • Study site

    Oak Forest, Illinois

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pharr, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Santa Maria, California

  • Study site

    Sarasota, Florida

  • Study site

    Seguin, Texas

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tallassee, Alabama

  • Study site

    Temple, Texas

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Warwick, Rhode Island

  • Study site

    Wheat Ridge, Colorado

  • 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 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Read the detailed description

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

Being tested
Dexlansoprazole MR, Placebo
Keywords
Erosive Esophagitis
Medical subject headings
Esophagitis, Peptic

What participants receive

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

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Dexilant, Kapidex

    Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.

  • PlaceboDrug

    Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Study groups in NCT00255151
Study groupRoleWhat they receive
Dexlansoprazole MR 60 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.

    Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.

    Measured: 6 months

  2. Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method

    Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.

    Measured: 6 months

Secondary outcomes (4)

  1. Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.

    The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.

    Measured: 6 months

  2. Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.

    The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked

    Measured: 6 months

  3. Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.

    The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

    Measured: 6 months

  4. Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.

    The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

    Measured: 6 months

Timeline

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

  1. First posted17 Nov 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2006
  4. Study completionNov 2006

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255151
Sponsor's protocol ID
T-EE04-087
Other IDs
U1111-1114-1767
Status last verified
Feb 2012
First submitted
15 Nov 2005
Last updated
3 Feb 2012
Data monitoring committee
No

Publications

  • Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.

    PubMed 19681809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole MR in people with Esophagitis, Reflux and Esophagitis, Peptic, run by Takeda at 100 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 4 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 3 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 100 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00255151, which also lists 1 linked publication.

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 3 Feb 2012.

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