Clinical trial NCT00251719: 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: 2054
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: This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) 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 and 90 mg) 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 up to 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 (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Primary outcomes:
measure: Percentage of Subjects With Complete Healing of Erosive Esophagitis 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: Week 8
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 Analysis.
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: Anniston
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tallassee
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Azusa
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Cypress
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Moline
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Oak Forest
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
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state: Indiana
city: Davenport
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state: Iowa
city: Kansas City
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state: Kansas
city: Wichita
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state: Kansas
city: Lexington
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state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Prince Frederick
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Egg Harbor Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mogadore
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state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Medford
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state: Oregon
city: Portland
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state: Oregon
city: Philadelphia
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state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Conroe
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Pharr
country: United States
state: Texas
city: Seguin
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Lakewood
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide
country: Australia
city: Bedford Park
country: Australia
city: Kippa Ring
country: Australia
city: Sofia
country: Bulgaria
city: Hamilton
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Cundinamarca
country: Colombia
state: Bogota
city: Barranquilla - Atlantico
country: Colombia
city: Hradec Kralove
country: Czech Republic
city: Ostrava - Hrabuvka
country: Czech Republic
city: Berlin
country: Germany
state: BE
city: Stuttgart
country: Germany
state: BW
city: Bochum
country: Germany
state: NW
city: Bratislava
country: Germany
city: Hyderabad
country: India
state: Andh Prad
city: Bangalore
country: India
state: Kama
city: Ludhiana
country: India
state: Punjab
city: Hyderabad
country: India
city: Pune
country: India
city: Hamburg
country: Latvia
state: HH
city: Balvi
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Panevezys
country: Lithuania
city: Vinius
country: Lithuania
city: Auckland
country: New Zealand
city: Lima
country: Peru
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Mangalore
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavi
country: Russian Federation
city: Daugavpils
country: Slovakia
city: Kosice
country: Slovakia
city: Presov
country: Slovakia
city: Bloemfontein
country: South Africa
state: Free State
city: Cape Town
country: South Africa
state: WC
city: Observatory, Cape Town
country: South Africa
state: WC
city: Parktown, Gauteng
country: South Africa
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
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.