Clinical trial NCT00321737: Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official title: A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 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: 2006-05-04
Enrollment: 445
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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Detailed description: This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

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.
* Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Need for continuous anticoagulant therapy.
* Evidence of uncontrolled systemic disease.
* Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
* Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

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: Huntsville
country: United States
state: Alabama
city: Tuscon
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Azusa
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Cypress
country: United States
state: California
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Harrisburg
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
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: Wheat Ridge
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyma Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Moline
country: United States
state: Illinois
city: Oak Forrest
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Hollywood
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Prince Federick
country: United States
state: Maryland
city: Chaska
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Egg Harbor Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Rochester
country: United States
state: New York
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: Bismark
country: United States
state: North Dakota
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: Duncansville
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
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: Ogden
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
city: Kippa Ring
country: Australia
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Newmarket
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Longueuil
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Hradec Kralove
country: Czech Republic
city: Tallinn
country: Estonia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
country: Lithuania
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Presov
country: Slovakia
city: Sucany
country: Slovakia
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_CHAIR
References:
citation: Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.
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.