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Esophagitis, RefluxPhase 3NCT00251719

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 144 sites in 16 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

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) 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
2,054 participants
Where
144 sitesin 16 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 (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Trial locations and contacts

144 sites in 16 countries.

144 sites in 16 countries

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

    Boise, Idaho

  • Study site

    Bristol, Connecticut

  • Study site

    Carmichael, California

  • 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

    Harrisburg, 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

    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

India5 sites

  • Study site

    Bangalore, Kama

  • Study site

    Hyderabad, Andh Prad

  • Study site

    Hyderabad

  • Study site

    Ludhiana, Punjab

  • Study site

    Pune

Other trials in India

Poland5 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Mangalore

  • Study site

    Warsaw

Other trials in Poland

Canada4 sites

  • Study site

    Hamilton, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    Saskatoon, Saskatchewan

Other trials in Canada

Germany4 sites

  • Study site

    Berlin, State of Berlin

  • Study site

    Bochum, North Rhine-Westphalia

  • Study site

    Bratislava

  • Study site

    Stuttgart, Baden-Wurttemberg

Other trials in Germany

Latvia4 sites

  • Study site

    Balvi

  • Study site

    Hamburg, HH

  • Study site

    Riga

  • Study site

    Valmiera

Other trials in Latvia

South Africa4 sites

  • Study site

    Bloemfontein, Free State

  • Study site

    Cape Town, WC

  • Study site

    Observatory, Cape Town, WC

  • Study site

    Parktown, Gauteng

Other trials in South Africa

Australia3 sites

  • Study site

    Adelaide

  • Study site

    Bedford Park

  • Study site

    Kippa-Ring

Other trials in Australia

Russia3 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Yaroslavi

Other trials in Russia

Slovakia3 sites

  • Study site

    Daugavpils

  • Study site

    Košice

  • Study site

    Prešov

Other trials in Slovakia

Colombia2 sites

  • Study site

    Barranquilla - Atlantico

  • Study site

    Cundinamarca, Bogota D.C.

Other trials in Colombia

Czechia2 sites

  • Study site

    Hradec Králové

  • Study site

    Ostrava - Hrabuvka

Other trials in Czechia

Lithuania2 sites

  • Study site

    Panevezys

  • Study site

    Vinius

Other trials in Lithuania

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

New Zealand1 site

  • Study site

    Auckland

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

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) 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 and 90 mg) 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 up to 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 NCT00251719
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 by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

    Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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 EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. 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: Week 8

  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. Change in LA Esophagitis Classification grades C or D to healed was measured. 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 Analysis.

    Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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
2,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251719
Sponsor's protocol ID
T-EE04-085
Other IDs
U1111-1114-0058
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 144 sites in 16 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 144 sites in United States, India, Poland, Canada, Germany and 11 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 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 NCT00251719, 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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