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Esophagitis, RefluxPhase 3NCT00321737

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo 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 98 sites in 8 countries.

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) 30 mg and 60 mg or 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
445 participants
Where
98 sitesin 8 countries
Study dates
May 2006to May 2007
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.
  • Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
  • Need for continuous anticoagulant therapy.
  • Evidence of uncontrolled systemic disease.
  • Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).
  • Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Trial locations and contacts

98 sites in 8 countries.

98 sites in 8 countries

United States80 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

    Azusa, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Binghamton, New York

  • Study site

    Bismarck, North Dakota

  • Study site

    Boise, Idaho

  • Study site

    Boulder, Colorado

  • Study site

    Boynton Beach, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Carmichael, California

  • Study site

    Charlottesville, Virginia

  • Study site

    Chaska, Minnesota

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chula Vista, California

  • Study site

    Clive, Iowa

  • Study site

    Colorado Springs, Colorado

  • Study site

    Cypress, California

  • Study site

    Dayton, Ohio

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Garden Grove, California

  • Study site

    Germantown, Tennessee

  • Study site

    Greensboro, North Carolina

  • Study site

    Harrisburg, California

  • Study site

    High Point, North Carolina

  • 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

    Jackson, Tennessee

  • Study site

    Jefferson City, Missouri

  • Study site

    Jupiter, Florida

  • Study site

    Kingsport, Tennessee

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Lutherville, Maryland

  • Study site

    Medford, Oregon

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mission Hills, California

  • Study site

    Mogadore, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Monroe, Wisconsin

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Smyma Beach, Florida

  • Study site

    Oak Forrest, Illinois

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Pasadena, California

  • Study site

    Portland, Oregon

  • Study site

    Prince Federick, Maryland

  • 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

    San Luis Obispo, California

  • Study site

    Spokane, Washington

  • Study site

    St. Petersburg, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tuscon, Arizona

  • Study site

    Washington, Missouri

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Zephyrhills, Florida

Other trials in United States

Canada6 sites

  • Study site

    Longueuil, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    Regina, Saskatchewan

  • Study site

    Richmond Hill, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

Other trials in Canada

Slovakia4 sites

  • Study site

    Bratislava

  • Study site

    Nitra

  • Study site

    Prešov

  • Study site

    Sučany

Other trials in Slovakia

Lithuania3 sites

  • Study site

    Kaunas

  • Study site

    Panevezys

  • Study site

    Vilnius

Other trials in Lithuania

Latvia2 sites

  • Study site

    Riga

  • Study site

    Valmiera

Other trials in Latvia

Australia1 site

  • Study site

    Kippa-Ring

Other trials in Australia

Czechia1 site

  • Study site

    Hradec Králové

Other trials in Czechia

Estonia1 site

  • Study site

    Tallinn

Other trials in Estonia

About this study

Official title: A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Read the detailed description

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

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 30 mg, capsules, orally, once daily for up to six months.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

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

  • PlaceboDrug

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

Study groups in NCT00321737
Study groupRoleWhat they receive
Dexlansoprazole MR 30 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 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 posted4 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2007
  4. Study completionMay 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321737
Sponsor's protocol ID
T-EE05-135
Other IDs
2006-000419-90, U1111-1113-9433
Status last verified
Feb 2012
First submitted
2 May 2006
Last updated
3 Feb 2012
Data monitoring committee
No

Publications

  • Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.

    PubMed 19210298

  • 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

  • Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.

    PubMed 21129076

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 98 sites in 8 countries.

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 8 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 98 sites in United States, Canada, Slovakia, Lithuania, Latvia and 3 more countries. 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 NCT00321737, which also lists 4 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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