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

June 27, 2016 updated by: Takeda

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States
      • Anniston, Alabama, United States
      • Birmingham, Alabama, United States
      • Hueytown, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Tallassee, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
      • North Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Azusa, California, United States
      • Carmichael, California, United States
      • Chula Vista, California, United States
      • Cypress, California, United States
      • Fresno, California, United States
      • Fullerton, California, United States
      • Garden Grove, California, United States
      • Irvine, California, United States
      • Lancaster, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Mission Hills, California, United States
      • Modesto, California, United States
      • Newport Beach, California, United States
      • Oakland, California, United States
      • Orange, California, United States
      • Palm Springs, California, United States
      • Pasadena, California, United States
      • Redwood City, California, United States
      • San Diego, California, United States
      • San Luis Obispo, California, United States
      • Santa Maria, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Littleton, Colorado, United States
      • Lone Tree, Colorado, United States
      • Longmont, Colorado, United States
      • Wheat Ridge, Colorado, United States
    • Connecticut
      • Bristol, Connecticut, United States
      • Waterbury, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Fort Myers, Florida, United States
      • Jacksonville, Florida, United States
      • Jupiter, Florida, United States
      • Kissimmee, Florida, United States
      • Lakeland, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • New Port Richey, Florida, United States
      • New Smyrna Beach, Florida, United States
      • Ocala, Florida, United States
      • Pembroke Pines, Florida, United States
      • Port Orange, Florida, United States
      • Sarasota, Florida, United States
      • St. Petersburg, Florida, United States
      • Zephyrhills, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Champaign, Illinois, United States
      • Chicago, Illinois, United States
      • Hines, Illinois, United States
      • Moline, Illinois, United States
      • North Chicago, Illinois, United States
      • Oak Forest, Illinois, United States
      • Oak Park, Illinois, United States
      • Rockford, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
      • Newburgh, Indiana, United States
    • Iowa
      • Clive, Iowa, United States
      • Davenport, Iowa, United States
      • Dubuque, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Newton, Kansas, United States
      • Shawnee Mission, Kansas, United States
      • Topeka, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Metairie, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Chevy Chase, Maryland, United States
      • Hollywood, Maryland, United States
      • Lutherville, Maryland, United States
      • Prince Frederick, Maryland, United States
    • Michigan
      • Troy, Michigan, United States
    • Minnesota
      • Chaska, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • Kansas City, Missouri, United States
      • Mexico, Missouri, United States
      • Saint Louis, Missouri, United States
      • Washington, Missouri, United States
    • Montana
      • Missoula, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Pahrump, Nevada, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
      • New Brunswick, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Binghamton, New York, United States
      • Brooklyn, New York, United States
      • Great Neck, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Elkin, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Harrisburg, North Carolina, United States
      • Hickory, North Carolina, United States
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Statesville, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinatti, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Mayfield Heights, Ohio, United States
      • Mogadore, Ohio, United States
      • Warren, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Mt. Pleasant, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
      • Hermitage, Tennessee, United States
      • Jackson, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Bryan, Texas, United States
      • Conroe, Texas, United States
      • Corsicana, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Odessa, Texas, United States
      • Pharr, Texas, United States
      • San Antonio, Texas, United States
      • Seguin, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Chesapeake, Virginia, United States
      • Danville, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Lakewood, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Monroe, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexlansoprazole MR 60 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
EXPERIMENTAL: Dexlansoprazole MR 90 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Month 12 for Hemoglobin Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Hematocrit Values
Time Frame: Baseline and Month 12
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Baseline and Month 12
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Platelet Count Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Creatinine Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Calcium Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Total Bilirubin Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
Time Frame: Baseline and Month 12
Baseline and Month 12
Mean Change From Baseline to Month 12 for Pulse Rate
Time Frame: Baseline and Month 12
Baseline and Month 12
Changes From Baseline to Final Visit in Antrum Biopsy Results
Time Frame: Baseline and Final Visit (up to 12 months)
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.
Baseline and Final Visit (up to 12 months)
Changes From Baseline to Final Visit in Fundus Biopsy Results
Time Frame: Baseline and Final Visit (up to 12 months)
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.
Baseline and Final Visit (up to 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
Time Frame: Baseline and Month 1
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.
Baseline and Month 1
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
Time Frame: Baseline and Month 3
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.
Baseline and Month 3
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
Time Frame: Baseline and Month 6
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.
Baseline and Month 6
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
Time Frame: Baseline and Month 9
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.
Baseline and Month 9
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
Time Frame: Baseline and Month 12
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.
Baseline and Month 12
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
Time Frame: Baseline and Month 1
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).
Baseline and Month 1
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
Time Frame: Baseline and Month 3
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).
Baseline and Month 3
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
Time Frame: Baseline and Month 6
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).
Baseline and Month 6
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
Time Frame: Baseline and Month 9
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).
Baseline and Month 9
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
Time Frame: Baseline and Month 12
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).
Baseline and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (ESTIMATE)

November 17, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-GI04-088
  • U1111-1114-0151 (REGISTRY: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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