Clinical trial NCT00321984: Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease(GERD)
Heartburn
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 947
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 efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Detailed description: This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
* Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
* Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

* Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
* Subjects with erosive esophagitis (EE) as shown by endoscopy.
* Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
* Subject has abnormal laboratory values.
* Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
* Subject known to have acquired immunodeficiency syndrome (AIDS).
* Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
* Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Use of antacids (except for study-supplied Gelusil® ).
* Use of drugs with significant anticholinergic effects.
* Subjects who cannot discontinue the use of misoprostol or prokinetics
* Need for continuous anticoagulant therapy.
* Females who are pregnant or lactating.
* History of gastrointestinal surgery except for simple oversew of ulcer.
* History of cancer within 3 years prior to screening.
* Subject has participated in a previous Dexlansoprazole study.
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Primary outcomes:
measure: Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
timeFrame: 4 weeks
measure: Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
timeFrame: 4 weeks
measure: Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Tallassee
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
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
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state: California
city: Clearwater
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state: California
city: Cypress
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city: Fountain Valley
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state: California
city: Fullerton
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state: California
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state: California
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city: Mission Hills
country: United States
state: California
city: Oakland
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city: Orange
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state: California
city: Palm Springs
country: United States
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city: San Diego
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city: Vista
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city: Westlake Village
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city: Boulder
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state: Colorado
city: Colorado Springs
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city: Lone Tree
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city: Wheat Ridge
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state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Waterbury
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state: Florida
city: Clearwater
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city: Holly Hill
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country: United States
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city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Conyers
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city: Oak Forrest
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city: Las Vegas
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state: New Jersey
city: Albuquerque
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city: Great Neck
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city: Greensboro
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city: High Point
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city: Raleigh
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city: Statesville
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city: Bismark
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state: North Dakota
city: Cincinnati
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city: Cleveland
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city: Columbus
country: United States
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city: Dayton
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Sylvania
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: Harleysville
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Levittown
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Varnville
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: Bellaire
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Carollton
country: United States
state: Texas
city: Conroe
country: United States
state: Texas
city: Corsicana
country: United States
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city: Dallas
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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: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Norfold
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
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: Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
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: 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.