Clinical trial NCT00255164: Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official title: A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed 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: 2005-11-17
Enrollment: 451
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 ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Detailed description: This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

Eligibility criteria: Inclusion Criteria:

* Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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.
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Need for continuous anticoagulant therapy.

Primary outcomes:
measure: Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
timeFrame: 6 months
measure: Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
timeFrame: 6 months
measure: Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
timeFrame: 6 months
measure: Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
timeFrame: 6 months
measure: Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
timeFrame: 6 months
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
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state: California
city: Garden Grove
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state: California
city: Irvine
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Long Beach
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state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
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state: California
city: Palm Springs
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state: California
city: Redwood City
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state: California
city: San Diego
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Boulder
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state: Colorado
city: Colorado Springs
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state: Colorado
city: Lone Tree
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state: Colorado
city: Wheat Ridge
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state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Jacksonville
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state: Florida
city: Jupiter
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state: Florida
city: Kissimmee
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state: Florida
city: Lakeland
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state: Florida
city: New Port Richey
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state: Florida
city: Atlanta
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state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Arlington Heights
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state: Illinois
city: Chicago
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state: Illinois
city: Hines
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state: Illinois
city: Oak Park
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state: Illinois
city: Rockford
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state: Illinois
city: Clive
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state: Iowa
city: Dubuque
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state: Iowa
city: Newton
country: United States
state: Kansas
city: Shawnee Mission
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state: Kansas
city: Topeka
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Hollywood
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Troy
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Mexico
country: United States
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: New Brunswick
country: United States
state: New Jersey
city: Bingampton
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: 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
country: United States
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: Bedford
country: United States
state: Texas
city: Bryan
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
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.
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.