Clinical trial NCT00255190: Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Official title: A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 591
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 determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Detailed description: This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions.

Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study.

After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months.

Approximately 200 study sites in the U.S. will participate.

For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

Eligibility criteria: Inclusion Criteria:

* Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

* Any condition that may require inpatient surgery during the course of the study.
* Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
* Use of antacids \[except for study supplied Gelusil®\].
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
* Evidence of uncontrolled systemic disease.
* Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
* Need to take blood thinners.
* Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
* Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
* Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
* Has had radiation or cryotherapy to the esophagus.
* Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
* Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
* History of alcohol abuse.
* Has acquired immunodeficiency syndrome.
* Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
* Received a blood product transfusion within 3 months of taking the first dose of study drug.
* Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.

Primary outcomes:
measure: Mean Change From Baseline to Month 12 for Hemoglobin Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Hematocrit Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Platelet Count Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for White Blood Cell Count Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Creatinine Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Calcium Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Total Bilirubin Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Serum Gastrin Levels
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Systolic Blood Pressure
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 12 for Pulse Rate
timeFrame: Baseline and Month 12
measure: Changes From Baseline to Final Visit in Antrum Biopsy Results
timeFrame: Baseline and Final Visit (up to 12 months)
measure: Changes From Baseline to Final Visit in Fundus Biopsy Results
timeFrame: Baseline and Final Visit (up to 12 months)
Secondary outcomes:
measure: Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
timeFrame: Baseline and Month 1
measure: Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
timeFrame: Baseline and Month 3
measure: Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
timeFrame: Baseline and Month 6
measure: Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
timeFrame: Baseline and Month 9
measure: Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
timeFrame: Baseline and Month 12
measure: Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
timeFrame: Baseline and Month 1
measure: Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
timeFrame: Baseline and Month 3
measure: Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
timeFrame: Baseline and Month 6
measure: Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
timeFrame: Baseline and Month 9
measure: Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Anniston
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state: Alabama
city: Birmingham
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state: Alabama
city: Hueytown
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state: Alabama
city: Huntsville
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state: Alabama
city: Mobile
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state: Arizona
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state: Arkansas
city: North Little Rock
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state: Arkansas
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state: California
city: Azusa
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state: California
city: Carmichael
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state: California
city: Chula Vista
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state: California
city: Long Beach
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city: Los Angeles
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city: Mission Hills
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state: California
city: Modesto
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city: Newport Beach
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city: Orange
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city: Palm Springs
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city: Redwood City
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city: San Diego
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city: Colorado Springs
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city: Champaign
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city: Hollywood
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city: Troy
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city: Chaska
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city: Jackson
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city: Jefferson City
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city: Mexico
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city: Saint Louis
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city: Omaha
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city: Pahrump
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city: Albuquerque
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city: Great Neck
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state: North Carolina
city: Charlotte
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city: Elkin
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city: Greensboro
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city: Harrisburg
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city: Hickory
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city: High Point
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city: Raleigh
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city: Salisbury
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city: Bismarck
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state: North Dakota
city: Akron
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state: Ohio
city: Cincinatti
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city: Columbus
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city: Dayton
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city: Mayfield Heights
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city: Mogadore
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state: Ohio
city: Warren
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state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Medford
country: United States
state: Oregon
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: 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: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Hermitage
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: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Conroe
country: United States
state: Texas
city: Corsicana
country: United States
state: Texas
city: Dallas
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: Odessa
country: United States
state: Texas
city: Pharr
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seguin
country: United States
state: Texas
city: Tyler
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: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Danville
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: 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
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
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: Dabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.
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.