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Gastroesophageal Reflux DiseasePhase 3NCT00255190

Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

A Phase 3 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux Disease, run by Takeda at 181 sites in United States.

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 determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
Dexlansoprazole MR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
591 participants
Where
181 sitesUnited States
Study dates
Jan 2006to Jun 2008
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 either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Who cannot join

  • Any condition that may require inpatient surgery during the course of the study.
  • Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
  • Use of antacids [except for study supplied Gelusil®].
  • Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
  • Evidence of uncontrolled systemic disease.
  • Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
Show all 18Show fewer
  • Need to take blood thinners.
  • Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
  • Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
  • Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
  • Has had radiation or cryotherapy to the esophagus.
  • Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
  • Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
  • History of alcohol abuse.
  • Has acquired immunodeficiency syndrome.
  • Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
  • Received a blood product transfusion within 3 months of taking the first dose of study drug.
  • Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.

Trial locations and contacts

181 sites in 1 country.

181 sites in 1 country

United States181 sites

  • Study site

    Akron, Ohio

  • Study site

    Alabaster, Alabama

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Anniston, Alabama

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Azusa, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beaumont, Texas

  • Study site

    Beaver Falls, Pennsylvania

  • Study site

    Bellevue, Washington

  • Study site

    Binghamton, New York

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boulder, Colorado

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Bristol, Connecticut

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Bryan, Texas

  • 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

    Chaska, Minnesota

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Conroe, Texas

  • Study site

    Corsicana, Texas

  • Study site

    Cypress, California

  • Study site

    Dallas, Texas

  • Study site

    Danville, Virginia

  • Study site

    Davenport, Iowa

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Dubuque, Iowa

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Egg Harbor, New Jersey

  • Study site

    El Paso, Texas

  • Study site

    Elkin, North Carolina

  • Study site

    Evansville, Indiana

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Fullerton, California

  • Study site

    Garden Grove, California

  • Study site

    Germantown, Tennessee

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Harrisburg, North Carolina

  • Study site

    Hermitage, Tennessee

  • Study site

    Hickory, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Hines, Illinois

  • Study site

    Hollywood, Maryland

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Hueytown, Alabama

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Irvine, California

  • Study site

    Jackson, Mississippi

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupiter, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Kissimmee, Florida

  • Study site

    Lakeland, Florida

  • Study site

    Lakewood, Washington

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Lone Tree, Colorado

  • Study site

    Long Beach, California

  • Study site

    Longmont, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lutherville, Maryland

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Medford, Oregon

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mission Hills, California

  • Study site

    Missoula, Montana

  • Study site

    Mobile, Alabama

  • Study site

    Modesto, California

  • Study site

    Mogadore, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Monroe, Wisconsin

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Port Richey, Florida

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Newark, Delaware

  • Study site

    Newburgh, Indiana

  • Study site

    Newport Beach, California

  • Study site

    Newton, Kansas

  • Study site

    Norfolk, Virginia

  • Study site

    North Chicago, Illinois

  • Study site

    North Little Rock, Arkansas

  • Study site

    Oak Forest, Illinois

  • Study site

    Oak Park, Illinois

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Springs, California

  • Study site

    Pasadena, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pharr, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Raleigh, North Carolina

  • Study site

    Redwood City, California

  • Study site

    Richmond, Virginia

  • 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

    Santa Maria, California

  • Study site

    Sarasota, Florida

  • Study site

    Scottsdale, Arizona

  • Study site

    Seguin, Texas

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Shreveport, Louisiana

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Statesville, North Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tallassee, Alabama

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Tyler, Texas

  • Study site

    Warren, Ohio

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington, Missouri

  • Study site

    Waterbury, Connecticut

  • Study site

    West Jordan, Utah

  • 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, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Read the detailed description

This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions.

Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study.

After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months.

Approximately 200 study sites in the U.S. will participate.

For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

Being tested
Dexlansoprazole MR
Keywords
Gastroesophageal Reflux Disease
Medical subject headings
Gastroesophageal Reflux

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 12 months.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.

Study groups in NCT00255190
Study groupRoleWhat they receive
Dexlansoprazole MR 60 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR

What is being measured

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

  1. Mean Change From Baseline to Month 12 for Hemoglobin Values

    Measured: Baseline and Month 12

  2. Mean Change From Baseline to Month 12 for Hematocrit Values

    Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.

    Measured: Baseline and Month 12

  3. Mean Change From Baseline to Month 12 for Red Blood Cell Count Values

    Measured: Baseline and Month 12

  4. Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values

    Measured: Baseline and Month 12

  5. Mean Change From Baseline to Month 12 for Platelet Count Values

    Measured: Baseline and Month 12

  6. Mean Change From Baseline to Month 12 for White Blood Cell Count Values

    Measured: Baseline and Month 12

  7. Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values

    Measured: Baseline and Month 12

  8. Mean Change From Baseline to Month 12 for Creatinine Values

    Measured: Baseline and Month 12

  9. Mean Change From Baseline to Month 12 for Calcium Values

    Measured: Baseline and Month 12

  10. Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values

    Measured: Baseline and Month 12

  11. Mean Change From Baseline to Month 12 for Total Bilirubin Values

    Measured: Baseline and Month 12

  12. Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values

    Measured: Baseline and Month 12

  13. Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values

    Measured: Baseline and Month 12

  14. Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values

    Measured: Baseline and Month 12

  15. Mean Change From Baseline to Month 12 for Serum Gastrin Levels

    Measured: Baseline and Month 12

  16. Mean Change From Baseline to Month 12 for Systolic Blood Pressure

    Measured: Baseline and Month 12

  17. Mean Change From Baseline to Month 12 for Diastolic Blood Pressure

    Measured: Baseline and Month 12

  18. Mean Change From Baseline to Month 12 for Pulse Rate

    Measured: Baseline and Month 12

  19. Changes From Baseline to Final Visit in Antrum Biopsy Results

    Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.

    Measured: Baseline and Final Visit (up to 12 months)

  20. Changes From Baseline to Final Visit in Fundus Biopsy Results

    Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.

    Measured: Baseline and Final Visit (up to 12 months)

Secondary outcomes (10)

  1. Mean Change From Baseline to Month 1 for PAGI-QOL Total Score

    Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

    Measured: Baseline and Month 1

  2. Mean Change From Baseline to Month 3 for PAGI-QOL Total Score

    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

    Measured: Baseline and Month 3

  3. Mean Change From Baseline to Month 6 for PAGI-QOL Total Score

    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

    Measured: Baseline and Month 6

  4. Mean Change From Baseline to Month 9 for PAGI-QOL Total Score

    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

    Measured: Baseline and Month 9

  5. Mean Change From Baseline to Month 12 for PAGI-QOL Total Score

    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

    Measured: Baseline and Month 12

  6. Mean Change From Baseline to Month 1 for PAGI-SYM Total Score

    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

    Measured: Baseline and Month 1

  7. Mean Change From Baseline to Month 3 for PAGI-SYM Total Score

    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

    Measured: Baseline and Month 3

  8. Mean Change From Baseline to Month 6 for PAGI-SYM Total Score

    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

    Measured: Baseline and Month 6

  9. Mean Change From Baseline to Month 9 for PAGI-SYM Total Score

    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

    Measured: Baseline and Month 9

  10. Mean Change From Baseline to Month 12 for PAGI-SYM Total Score

    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

    Measured: Baseline and Month 12

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 completionJun 2008
  4. Study completionJun 2008

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
None (open label)
Enrolment
591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255190
Sponsor's protocol ID
T-GI04-088
Other IDs
U1111-1114-0151
Status last verified
Apr 2011
First submitted
15 Nov 2005
Last updated
27 Jul 2016
Data monitoring committee
No

Publications

  • 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

  • Dabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.

    PubMed 21118280

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux Disease, run by Takeda at 181 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 18 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 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 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. 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 12 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?

Mean Change From Baseline to Month 12 for Hemoglobin Values (time frame: Baseline and Month 12). The study lists 20 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 NCT00255190, 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 27 Jul 2016.

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