Clinical trial NCT00255151: Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain 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 (NCT00255164) and T-EE04-087 (this study, 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 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.
* 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: 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
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state: California
city: Los Angeles
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state: California
city: Modesto
country: United States
state: California
city: Newport Beach
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state: California
city: Oakland
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state: California
city: Orange
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state: California
city: San Diego
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state: California
city: Santa Maria
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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
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state: Delaware
city: Fort Myers
country: United States
state: Florida
city: Miami
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state: Florida
city: Naples
country: United States
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city: New Smyrna Beach
country: United States
state: Florida
city: Ocala
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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
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state: Georgia
city: Champaign
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Oak Forest
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state: Illinois
city: Springfield
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state: Illinois
city: Evansville
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state: Indiana
city: Indianapolis
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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
country: United States
state: Kansas
city: Lexington
country: United States
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: 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
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
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
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_CHAIR
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.