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Esophagitis, RefluxPhase 3NCT00251693

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

A Phase 3 study testing Dexlansoprazole MR and Lansoprazole in people with Esophagitis, Reflux and Esophagitis, Peptic, run by Takeda at 140 sites in 15 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or 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, Reflux, Esophagitis, Peptic
What is being tested?
Dexlansoprazole MR and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,038 participants
Where
140 sitesin 15 countries
Study dates
Dec 2005to Jan 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

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

Who cannot join

  • Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
  • Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
  • Use of antacids [except for study supplied Gelusil®]
  • Need for continuous anticoagulant therapy (blood thinners)
  • Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
  • History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Show all 9Show fewer
  • Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
  • History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
  • Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy

Trial locations and contacts

140 sites in 15 countries.

140 sites in 15 countries

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

    Beachwood, Ohio

  • Study site

    Beaumont, Texas

  • Study site

    Beaver Falls, Pennsylvania

  • Study site

    Binghamton, 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

    Byran, 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

    Jacksonsville, 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 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

    Pasadena, 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

India10 sites

  • Study site

    Chennai

  • Study site

    Coimbatore

  • Study site

    Gujarat, Ahmedabad

  • Study site

    Hyderabad

  • Study site

    Ludhiana, Punjab

  • Study site

    Madurai, Tamina

  • Study site

    New Delhi

  • Study site

    Rajasthan, Jaipur

  • Study site

    Tamilnadu, Chennai

  • Study site

    Visakhapatnam

Other trials in India

South Africa7 sites

  • Study site

    Cape Town, WC

  • Study site

    Gauteng, Johannesburg

  • Study site

    Panorama, WC

  • Study site

    Pinelands, WC

  • Study site

    Plumstead, WC

  • Study site

    Pretoria

  • Study site

    Somerset West, WC

Other trials in South Africa

Canada6 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Québec, Quebec

  • Study site

    Regina, Saskatchewan

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Germany4 sites

  • Study site

    Borna, Saxony

  • Study site

    Dietzenback, Hesse

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg

  • Study site

    Schweim, North Rhine-Westphalia

Other trials in Germany

Poland4 sites

  • Study site

    Krakow

  • Study site

    Lubin

  • Study site

    Sopot

  • Study site

    Warzawa

Other trials in Poland

Slovakia4 sites

  • Study site

    Bratislava

  • Study site

    Nitra

  • Study site

    Sučany

  • Study site

    Tmava

Other trials in Slovakia

Australia2 sites

  • Study site

    Box Hill

  • Study site

    South Brisbane

Other trials in Australia

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

Czechia1 site

  • Study site

    Prague

Other trials in Czechia

Hungary1 site

  • Study site

    Gyula

Other trials in Hungary

Latvia1 site

  • Study site

    Riga

Other trials in Latvia

Lithuania1 site

  • Study site

    Kaunas

Other trials in Lithuania

New Zealand1 site

  • Study site

    Hamilton

Other trials in New Zealand

Peru1 site

  • Study site

    Lima

Other trials in Peru

About this study

Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 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 once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Read the detailed description

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

Being tested
Dexlansoprazole MR, Lansoprazole
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 (QD) for up to 8 weeks.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.

  • LansoprazoleDrug

    Also called Prevacid, AG-1749

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

Study groups in NCT00251693
Study groupRoleWhat they receive
Dexlansoprazole MR 60 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
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. Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.

    Measured: 8 Weeks

  2. Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

    Measured: 8 weeks

Secondary outcomes (4)

  1. Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

    Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

    Measured: 8 Weeks

  2. Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

    Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

    Measured: 8 Weeks

  3. Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.

    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

    Measured: 4 Weeks

  4. Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.

    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

    Measured: 4 Weeks

Timeline

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

  1. First posted10 Nov 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionJan 2007
  4. Study completionJan 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
2,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251693
Sponsor's protocol ID
T-EE04-084
Other IDs
U1111-1113-9373
Status last verified
Feb 2012
First submitted
8 Nov 2005
Last updated
3 Feb 2012
Data monitoring committee
No

Publications

  • Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.

    PubMed 19183157

  • 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

  • Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.

    PubMed 24118079

  • Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. The effects of increasing body mass index on heartburn severity, frequency and response to treatment with dexlansoprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Apr;37(8):810-8. doi: 10.1111/apt.12270. Epub 2013 Mar 4.

    PubMed 23451835

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole MR and Lansoprazole in people with Esophagitis, Reflux and Esophagitis, Peptic, run by Takeda at 140 sites in 15 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 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 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 140 sites in United States, India, South Africa, Canada, Germany and 10 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. 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 23 Mar 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 With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. (time frame: 8 Weeks). 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 NCT00251693, which also lists 6 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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