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Gastroesophageal Reflux DiseasePhase 3NCT00321984

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

A Phase 3 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux Disease, run by Takeda at 153 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 assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD). 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?
Yes, some participants may receive a placebo
How many people
947 participants
Where
153 sitesUnited States
Study dates
Jun 2006to Dec 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 identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
  • Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
  • Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Who cannot join

  • Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
  • Subjects with erosive esophagitis (EE) as shown by endoscopy.
  • Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
  • Subject has abnormal laboratory values.
  • Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
  • Subject known to have acquired immunodeficiency syndrome (AIDS).
Show all 18Show fewer
  • Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
  • Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
  • Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
  • Use of antacids (except for study-supplied Gelusil® ).
  • Use of drugs with significant anticholinergic effects.
  • Subjects who cannot discontinue the use of misoprostol or prokinetics
  • Need for continuous anticoagulant therapy.
  • Females who are pregnant or lactating.
  • History of gastrointestinal surgery except for simple oversew of ulcer.
  • History of cancer within 3 years prior to screening.
  • Subject has participated in a previous Dexlansoprazole study.
  • Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Trial locations and contacts

153 sites in 1 country.

153 sites in 1 country

United States153 sites

  • Study site

    Alabaster, Alabama

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Azusa, California

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beaumont, Texas

  • Study site

    Bellaire, Texas

  • Study site

    Binghamton, New York

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boise, Idaho

  • Study site

    Boulder, Colorado

  • Study site

    Boynton Beach, Florida

  • Study site

    Bristol, Connecticut

  • Study site

    Bristol, Tennessee

  • Study site

    Bryan, Texas

  • Study site

    Butte, Montana

  • Study site

    Carmichael, California

  • Study site

    Carollton, Texas

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South 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

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, California

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Conroe, Texas

  • Study site

    Conyers, Georgia

  • Study site

    Corsicana, Texas

  • Study site

    Cypress, California

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Dubuque, Iowa

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Dunwoody, Georgia

  • Study site

    Egg Harbor Town, New Jersey

  • Study site

    El Paso, Texas

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Franklin, Ohio

  • 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

    Harleysville, Pennsylvania

  • Study site

    Harrisburg, North Carolina

  • Study site

    Hermitage, Tennessee

  • Study site

    High Point, North Carolina

  • Study site

    Holly Hill, Florida

  • 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

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupitor, Florida

  • Study site

    Kettering, Ohio

  • Study site

    Kingsport, Tennessee

  • Study site

    Kissimmee, Florida

  • Study site

    Lake Jackson, Texas

  • Study site

    Lakewood, Washington

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Littleton, Colorado

  • Study site

    Lone Tree, Colorado

  • Study site

    Louisville, Kentucky

  • Study site

    Lutherville, Maryland

  • Study site

    Lyndhurst, Ohio

  • Study site

    Medford, Oregon

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Miami, Florida

  • Study site

    Midvale, Utah

  • 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

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Smyma Beach, Florida

  • Study site

    Norfold, Virginia

  • Study site

    North Little Rock, Arizona

  • Study site

    Northport, Alabama

  • Study site

    Oak Forrest, Illinois

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orange, California

  • Study site

    Overland, Kansas

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Springs, California

  • Study site

    Pasadena, California

  • Study site

    Pembroke Pines, 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

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    San Luis Obispo, California

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spokane, Washington

  • Study site

    St. Petersburg, Florida

  • Study site

    Statesville, North Carolina

  • Study site

    Stockbridge, Georgia

  • Study site

    Sun City, Arizona

  • Study site

    Sylvania, Ohio

  • Study site

    Tacoma, Washington

  • Study site

    Tallassee, Alabama

  • Study site

    Tempe, Arizona

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Varnville, South Carolina

  • Study site

    Vista, California

  • Study site

    Washington, Missouri

  • Study site

    Waterbury, Connecticut

  • Study site

    West Palm Beach, Florida

  • Study site

    Westlake Village, California

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita, Kansas

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Read the detailed description

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Being tested
Dexlansoprazole MR, Placebo
Keywords
Gastroesophageal Reflux Disease(GERD), Heartburn
Medical subject headings
Gastroesophageal Reflux, Heartburn

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 4 weeks.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

    Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

  • PlaceboDrug

    Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Study groups in NCT00321984
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 Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic 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 marked.

    Measured: 4 weeks

  2. Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic 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: 4 weeks

Secondary outcomes (2)

  1. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic 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: 4 weeks

  2. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic 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: 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 posted4 May 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2006
  4. Study completionDec 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
947 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321984
Sponsor's protocol ID
T-GD05-137
Other IDs
2006-000420-13, U1111-1114-1935
Status last verified
Apr 2011
First submitted
2 May 2006
Last updated
28 Apr 2011
Data monitoring committee
No

Publications

  • Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.

    PubMed 19392864

  • 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

  • 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 in people with Gastroesophageal Reflux Disease, run by Takeda at 153 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 3 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 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 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 Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median (time frame: 4 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 NCT00321984, which also lists 5 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 28 Apr 2011.

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