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Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00251693
First received: November 8, 2005
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.


Condition Intervention Phase
Esophagitis, Reflux
Esophagitis, Peptic
 Drug: Dexlansoprazole MR
Drug: Lansoprazole
 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 Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.

  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.


Secondary Outcome Measures:
  • Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

  • Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.


Enrollment: 2038
Study Start Date: December 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole MR 60 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 90 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Active Comparator: Lansoprazole 30 mg QD Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Other Names:
  • Prevacid
  • AG-1749

Detailed Description:

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

  Eligibility

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

Inclusion Criteria:

  • Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

  • Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
  • Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
  • Use of antacids [except for study supplied Gelusil®]
  • Need for continuous anticoagulant therapy (blood thinners)
  • Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
  • History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
  • Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
  • History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
  • Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251693

  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
United States, California
Anaheim, California, United States
Chula Vista, 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
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
United States, Colorado
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Lone Tree, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, Florida
Boynton Beach, Florida, United States
Jacksonsville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Lakeland, Florida, United States
New Port Richey, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Illinois
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Hines, Illinois, United States
Oak Park, Illinois, United States
Rockford, Illinois, United States
United States, Iowa
Clive, Iowa, United States
Dubuque, Iowa, United States
United States, Kansas
Newton, Kansas, United States
Shawnee Mission, Kansas, United States
Topeka, Kansas, United States
United States, Louisiana
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Hollywood, Maryland, United States
Lutherville, Maryland, United States
United States, Michigan
Troy, Michigan, United States
United States, Minnesota
Chaska, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Mexico, Missouri, United States
Saint Louis, Missouri, United States
Washington, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Pahrump, Nevada, United States
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
United States, North Carolina
Charlotte, North Carolina, United States
Elkin, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Mayfield Heights, Ohio, United States
Warren, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Beaver Falls, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
United States, Tennessee
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Hermitage, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Beaumont, Texas, United States
Byran, Texas, United States
Corsicana, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Chesapeake, Virginia, United States
Danville, Virginia, United States
United States, Washington
Spokane, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Australia
Box Hill, Australia
South Brisbane, Australia
Bulgaria
Sofia, Bulgaria
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada
Canada, Quebec
Quebec City, Quebec, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Czech Republic
Praha 6, Czech Republic
Germany
Dietzenback, HE, Germany
Hamburg, HH, Germany
Schweim, NW, Germany
Borna, SN, Germany
Hungary
Gyula, Hungary
India
Gujarat, Ahmedabad, India
Tamilnadu, Chennai, India
Rajasthan, Jaipur, India
Ludhiana, Punjab, India
Madurai, Tamina, India
Chennai, India
Coimbatore, India
Hyderabad, India
New Delhi, India
Vishakapatnam, India
Latvia
Riga, Latvia
Lithuania
Kaunas, Lithuania
New Zealand
Hamilton, New Zealand
Peru
Lima, Peru
Poland
Krakow, Poland
Lubin, Poland
Sopot, Poland
Warzawa, Poland
Slovakia
Bratislava, Slovakia
Nitra, Slovakia
Sucany, Slovakia
Tmava, Slovakia
South Africa
Gauteng, Johannesburg, South Africa
Cape Town, WC, South Africa
Panorama, WC, South Africa
Pinelands, WC, South Africa
Plumstead, WC, South Africa
Somerset West, WC, South Africa
Pretoria, South Africa
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Chair: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

Additional Information:
For the Dexilant Package Insert refer to this link  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to this link  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00251693     History of Changes
Other Study ID Numbers: T-EE04-084, U1111-1113-9373
Study First Received: November 8, 2005
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Erosive Esophagitis

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

ClinicalTrials.gov processed this record on May 22, 2013