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

Last updated: June 27, 2016
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT00255190
T-GI04-088
U1111-1114-0151
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have successfully completed either T-GD04-082 (NCT00251745) orT-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease withor without erosive esophagitis.

Exclusion

Exclusion Criteria:

  • 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 whocannot 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.

  • 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 requiringdilation.

  • 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 studydrug.

  • Has previously participated in another dexlansoprazole MR long-term treatment clinicaltrial.

Study Design

Total Participants: 591
Study Start date:
January 01, 2006
Estimated Completion Date:
June 30, 2008

Study 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.

Connect with a study center

  • Alabaster, Alabama
    United States

    Site Not Available

  • Anniston, Alabama
    United States

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Hueytown, Alabama
    United States

    Site Not Available

  • Huntsville, Alabama
    United States

    Site Not Available

  • Mobile, Alabama
    United States

    Site Not Available

  • Tallassee, Alabama
    United States

    Site Not Available

  • Tuscaloosa, Alabama
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Scottsdale, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Little Rock, Arkansas
    United States

    Site Not Available

  • North Little Rock, Arkansas
    United States

    Site Not Available

  • Anaheim, California
    United States

    Site Not Available

  • Azusa, California
    United States

    Site Not Available

  • Carmichael, California
    United States

    Site Not Available

  • Chula Vista, California
    United States

    Site Not Available

  • Cypress, California
    United States

    Site Not Available

  • Fresno, California
    United States

    Site Not Available

  • Fullerton, California
    United States

    Site Not Available

  • Garden Grove, California
    United States

    Site Not Available

  • Irvine, California
    United States

    Site Not Available

  • Lancaster, California
    United States

    Site Not Available

  • Long Beach, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Mission Hills, California
    United States

    Site Not Available

  • Modesto, California
    United States

    Site Not Available

  • Newport Beach, California
    United States

    Site Not Available

  • Oakland, California
    United States

    Site Not Available

  • Orange, California
    United States

    Site Not Available

  • Palm Springs, California
    United States

    Site Not Available

  • Pasadena, California
    United States

    Site Not Available

  • Redwood City, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • San Luis Obispo, California
    United States

    Site Not Available

  • Santa Maria, California
    United States

    Site Not Available

  • Boulder, Colorado
    United States

    Site Not Available

  • Colorado Springs, Colorado
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Littleton, Colorado
    United States

    Site Not Available

  • Lone Tree, Colorado
    United States

    Site Not Available

  • Longmont, Colorado
    United States

    Site Not Available

  • Wheat Ridge, Colorado
    United States

    Site Not Available

  • Waterbury, Connecticut
    United States

    Site Not Available

  • Newark, Delaware
    United States

    Site Not Available

  • Boynton Beach, Florida
    United States

    Site Not Available

  • Fort Myers, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • Jupiter, Florida
    United States

    Site Not Available

  • Kissimmee, Florida
    United States

    Site Not Available

  • Lakeland, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Naples, Florida
    United States

    Site Not Available

  • New Port Richey, Florida
    United States

    Site Not Available

  • New Smyrna Beach, Florida
    United States

    Site Not Available

  • Ocala, Florida
    United States

    Site Not Available

  • Pembroke Pines, Florida
    United States

    Site Not Available

  • Port Orange, Florida
    United States

    Site Not Available

  • Sarasota, Florida
    United States

    Site Not Available

  • St. Petersburg, Florida
    United States

    Site Not Available

  • Zephyrhills, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Honolulu, Hawaii
    United States

    Site Not Available

  • Arlington Heights, Illinois
    United States

    Site Not Available

  • Champaign, Illinois
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Hines, Illinois
    United States

    Site Not Available

  • Moline, Illinois
    United States

    Site Not Available

  • North Chicago, Illinois
    United States

    Site Not Available

  • Oak Forest, Illinois
    United States

    Site Not Available

  • Oak Park, Illinois
    United States

    Site Not Available

  • Rockford, Illinois
    United States

    Site Not Available

  • Springfield, Illinois
    United States

    Site Not Available

  • Evansville, Indiana
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • Newburgh, Indiana
    United States

    Site Not Available

  • Clive, Iowa
    United States

    Site Not Available

  • Davenport, Iowa
    United States

    Site Not Available

  • Dubuque, Iowa
    United States

    Site Not Available

  • Kansas City, Kansas
    United States

    Site Not Available

  • Newton, Kansas
    United States

    Site Not Available

  • Shawnee Mission, Kansas
    United States

    Site Not Available

  • Topeka, Kansas
    United States

    Site Not Available

  • Wichita, Kansas
    United States

    Site Not Available

  • Lexington, Kentucky
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

  • Baton Rouge, Louisiana
    United States

    Site Not Available

  • Metairie, Louisiana
    United States

    Site Not Available

  • Shreveport, Louisiana
    United States

    Site Not Available

  • Chevy Chase, Maryland
    United States

    Site Not Available

  • Hollywood, Maryland
    United States

    Site Not Available

  • Lutherville, Maryland
    United States

    Site Not Available

  • Prince Frederick, Maryland
    United States

    Site Not Available

  • Troy, Michigan
    United States

    Site Not Available

  • Chaska, Minnesota
    United States

    Site Not Available

  • Jefferson City, Missouri
    United States

    Site Not Available

  • Mexico, Missouri
    United States

    Site Not Available

  • Saint Louis, Missouri
    United States

    Site Not Available

  • Washington, Missouri
    United States

    Site Not Available

  • Missoula, Montana
    United States

    Site Not Available

  • Omaha, Nebraska
    United States

    Site Not Available

  • Pahrump, Nevada
    United States

    Site Not Available

  • Egg Harbor Township, New Jersey
    United States

    Site Not Available

  • New Brunswick, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Binghamton, New York
    United States

    Site Not Available

  • Brooklyn, New York
    United States

    Site Not Available

  • Great Neck, New York
    United States

    Site Not Available

  • Rochester, New York
    United States

    Site Not Available

  • Chapel Hill, North Carolina
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • Elkin, North Carolina
    United States

    Site Not Available

  • Greensboro, North Carolina
    United States

    Site Not Available

  • Harrisburg, North Carolina
    United States

    Site Not Available

  • Hickory, North Carolina
    United States

    Site Not Available

  • High Point, North Carolina
    United States

    Site Not Available

  • Raleigh, North Carolina
    United States

    Site Not Available

  • Salisbury, North Carolina
    United States

    Site Not Available

  • Statesville, North Carolina
    United States

    Site Not Available

  • Wilmington, North Carolina
    United States

    Site Not Available

  • Winston Salem, North Carolina
    United States

    Site Not Available

  • Bismarck, North Dakota
    United States

    Site Not Available

  • Akron, Ohio
    United States

    Site Not Available

  • Cincinatti, Ohio
    United States

    Site Not Available

  • Columbus, Ohio
    United States

    Site Not Available

  • Dayton, Ohio
    United States

    Site Not Available

  • Mayfield Heights, Ohio
    United States

    Site Not Available

  • Mogadore, Ohio
    United States

    Site Not Available

  • Warren, Ohio
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Medford, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Beaver Falls, Pennsylvania
    United States

    Site Not Available

  • Duncansville, Pennsylvania
    United States

    Site Not Available

  • Lansdale, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Warwick, Rhode Island
    United States

    Site Not Available

  • Anderson, South Carolina
    United States

    Site Not Available

  • Mt. Pleasant, South Carolina
    United States

    Site Not Available

  • Sioux Falls, South Dakota
    United States

    Site Not Available

  • Bristol, Tennessee
    United States

    Site Not Available

  • Chattanooga, Tennessee
    United States

    Site Not Available

  • Germantown, Tennessee
    United States

    Site Not Available

  • Hermitage, Tennessee
    United States

    Site Not Available

  • Jackson, Tennessee
    United States

    Site Not Available

  • Johnson City, Tennessee
    United States

    Site Not Available

  • Kingsport, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Amarillo, Texas
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Beaumont, Texas
    United States

    Site Not Available

  • Bryan, Texas
    United States

    Site Not Available

  • Conroe, Texas
    United States

    Site Not Available

  • Corsicana, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • El Paso, Texas
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Odessa, Texas
    United States

    Site Not Available

  • Pharr, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Seguin, Texas
    United States

    Site Not Available

  • Tyler, Texas
    United States

    Site Not Available

  • Bountiful, Utah
    United States

    Site Not Available

  • Ogden, Utah
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • West Jordan, Utah
    United States

    Site Not Available

  • Charlottesville, Virginia
    United States

    Site Not Available

  • Chesapeake, Virginia
    United States

    Site Not Available

  • Danville, Virginia
    United States

    Site Not Available

  • Norfolk, Virginia
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • Bellevue, Washington
    United States

    Site Not Available

  • Lakewood, Washington
    United States

    Site Not Available

  • Spokane, Washington
    United States

    Site Not Available

  • Tacoma, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

  • Monroe, Wisconsin
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.