Clinical trial NCT00251693: Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophagitis, Reflux
Esophagitis, Peptic
Keywords: Erosive Esophagitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-11-10
Enrollment: 2038
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
timeFrame: 8 Weeks
measure: Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 Weeks
measure: 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.
timeFrame: 8 Weeks
measure: Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.
timeFrame: 4 Weeks
measure: Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Redwood City
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Lone Tree
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Jacksonsville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Hines
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Dubuque
country: United States
state: Iowa
city: Newton
country: United States
state: Kansas
city: Shawnee Mission
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Metairie
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state: Louisiana
city: Shreveport
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state: Louisiana
city: Hollywood
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Troy
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state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Mexico
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state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Pahrump
country: United States
state: Nevada
city: Binghamton
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Elkin
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
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state: Oregon
city: Beaver Falls
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Hermitage
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Byran
country: United States
state: Texas
city: Corsicana
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Danville
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
city: Box Hill
country: Australia
city: South Brisbane
country: Australia
city: Sofia
country: Bulgaria
city: Edmonton
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Quebec City
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
city: Praha 6
country: Czech Republic
city: Dietzenback
country: Germany
state: HE
city: Hamburg
country: Germany
state: HH
city: Schweim
country: Germany
state: NW
city: Borna
country: Germany
state: SN
city: Gyula
country: Hungary
city: Gujarat
country: India
state: Ahmedabad
city: Tamilnadu
country: India
state: Chennai
city: Rajasthan
country: India
state: Jaipur
city: Ludhiana
country: India
state: Punjab
city: Madurai
country: India
state: Tamina
city: Chennai
country: India
city: Coimbatore
country: India
city: Hyderabad
country: India
city: New Delhi
country: India
city: Vishakapatnam
country: India
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Hamilton
country: New Zealand
city: Lima
country: Peru
city: Krakow
country: Poland
city: Lubin
country: Poland
city: Sopot
country: Poland
city: Warzawa
country: Poland
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Sucany
country: Slovakia
city: Tmava
country: Slovakia
city: Gauteng
country: South Africa
state: Johannesburg
city: Cape Town
country: South Africa
state: WC
city: Panorama
country: South Africa
state: WC
city: Pinelands
country: South Africa
state: WC
city: Plumstead
country: South Africa
state: WC
city: Somerset West
country: South Africa
state: WC
city: Pretoria
country: South Africa
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_CHAIR
References:
citation: Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.
citation: 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.
citation: Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
citation: 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.
citation: 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.
citation: 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.