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Esophagitis, RefluxPhase 3NCT00255164

Efficacy and Safety of Dexlansoprazole MR on Maintaining 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 96 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
96 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 TEE04-085 (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

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Study site

    Alabaster, Alabama

  • Study site

    Anaheim, California

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Beaumont, Texas

  • Study site

    Beaver Falls, Pennsylvania

  • Study site

    Bedford, Texas

  • Study site

    Bingampton, New York

  • Study site

    Birmingham, Alabama

  • Study site

    Boulder, Colorado

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Bryan, Texas

  • Study site

    Charlotte, North Carolina

  • Study site

    Chaska, Minnesota

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colorado Springs, Colorado

  • Study site

    Corsicana, Texas

  • Study site

    Danville, Virginia

  • Study site

    Dubuque, Iowa

  • Study site

    Duncansville, Pennsylvania

  • Study site

    El Paso, Texas

  • Study site

    Elkin, North Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Fullerton, California

  • Study site

    Garden Grove, California

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Hermitage, Tennessee

  • Study site

    Hickory, North Carolina

  • Study site

    Hines, Illinois

  • Study site

    Hollywood, Maryland

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Kissimmee, Florida

  • Study site

    Lakeland, Florida

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lone Tree, Colorado

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Lutherville, Maryland

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mission Hills, California

  • Study site

    Monroe, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Port Richey, Florida

  • Study site

    Newton, Kansas

  • Study site

    Oak Park, Illinois

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Springs, California

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Redwood City, California

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Luis Obispo, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Statesville, North Carolina

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Warren, Ohio

  • Study site

    Washington, Missouri

  • Study site

    Waterbury, Connecticut

  • Study site

    West Jordan, Utah

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Winston-Salem, North Carolina

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 (this study, NCT00255164) and T-EE04-087 (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, Kapidex, Dexilant

    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 NCT00255164
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
NCT00255164
Sponsor's protocol ID
T-EE04-086
Other IDs
U1111-1114-1355
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

  • Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.

    PubMed 19735233

  • Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.

    PubMed 20195905

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 96 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 96 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 NCT00255164, which also lists 3 linked publications.

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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