Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00321737
First received: May 2, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).


Condition Intervention Phase
Esophagitis, Reflux
Esophagitis, Peptic
Drug: Dexlansoprazole MR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.

  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.


Secondary Outcome Measures:
  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 reported.

  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 445
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole MR 30 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 60 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Placebo Comparator: Placebo Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Detailed Description:

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

  • Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
  • Use of antacids (except for study supplied) throughout the study.
  • Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
  • Need for continuous anticoagulant therapy.
  • Evidence of uncontrolled systemic disease.
  • Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).
  • Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321737

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Tuscon, Arizona, United States
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
Garden Grove, California, United States
Harrisburg, California, United States
Irvine, California, United States
Lancaster, California, United States
Mission Hills, California, United States
Oakland, California, United States
Orange, California, United States
Pasadena, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
United States, Colorado
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Florida
Boynton Beach, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
New Smyma Beach, Florida, United States
Ocala, Florida, United States
St. Petersburg, Florida, United States
Zephyrhills, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Moline, Illinois, United States
Oak Forrest, Illinois, United States
Rockford, Illinois, United States
United States, Iowa
Clive, Iowa, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
United States, Maryland
Chevy Chase, Maryland, United States
Hollywood, Maryland, United States
Lutherville, Maryland, United States
Prince Federick, Maryland, United States
United States, Minnesota
Chaska, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Jefferson City, Missouri, United States
Washington, Missouri, United States
United States, New Jersey
Egg Harbor Township, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Binghamton, New York, United States
Rochester, New York, United States
United States, North Carolina
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
United States, North Dakota
Bismark, North Dakota, United States
United States, Ohio
Dayton, Ohio, United States
Mogadore, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
United States, South Carolina
Anderson, South Carolina, United States
Mount Pleasant, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Amarillo, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Ogden, Utah, United States
United States, Virginia
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
United States, Washington
Spokane, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Australia
Kippa Ring, Australia
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Newmarket, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Longueuil, Quebec, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada
Czech Republic
Hradec Kralove, Czech Republic
Estonia
Tallinn, Estonia
Latvia
Riga, Latvia
Valmiera, Latvia
Lithuania
Kaunas, Lithuania
Panevezys, Lithuania
Vilnius, Lithuania
Slovakia
Bratislava, Slovakia
Nitra, Slovakia
Presov, Slovakia
Sucany, Slovakia
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Medical Director Takeda
  More Information

Additional Information:
Publications:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00321737     History of Changes
Other Study ID Numbers: T-EE05-135, 2006-000419-90, U1111-1113-9433
Study First Received: May 2, 2006
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Erosive Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014