Clinical trial NCT00251745: Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Non-Erosive Gastroesophageal Reflux Disease (GERD)
Heartburn
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-11-10
Enrollment: 908
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 daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with 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 daily Dexlansoprazole MR (60 mg and 90 mg) 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 non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. 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.

Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (this posting, NCT00241745) and T-GD04-083 (NCT00251758), were combined and analyzed as a single larger study referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

Eligibility criteria: Inclusion Criteria:

* Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
* History of episodes of heartburn for 6 months or longer prior to screening.
* History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
* Use of antacids (except for study supplied Gelusil®).
* Use of drugs with significant anticholinergic effects.
* Need for continuous anticoagulant (blood thinner) therapy.
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
* History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter).
* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
* Erosive Esophagitis seen on endoscopy during study screening.
* Co-existing diseases affecting the esophagus.
* Abnormal laboratory values that suggest significant clinical disease.
* Known acquired immunodeficiency syndrome (AIDS)
* Females pregnant or lactating.
* History of Alcohol abuse.
* History of Cancer within 3 years prior to screening.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
* 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
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city: Huntsville
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state: Arizona
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city: Omaha
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state: Nebraska
city: Pahrump
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state: Nevada
city: New Brunswick
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state: New Jersey
city: Binghamton
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city: Brooklyn
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city: Great Neck
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city: Elkin
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city: Greensboro
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city: Hickory
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city: Winston Salem
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city: Cincinnati
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city: Mayfield Heights
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city: Warren
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city: Oklahoma City
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city: Portland
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state: Oregon
city: Beaver Falls
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state: Pennsylvania
city: Duncansville
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state: Pennsylvania
city: Lansdale
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state: Pennsylvania
city: Bristol
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city: Chattanooga
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city: Hermitage
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city: Beaumont
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city: Bryan
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state: Texas
city: El Paso
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state: Texas
city: Fort Worth
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city: Houston
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city: San Antonio
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state: Texas
city: Bountiful
country: United States
state: Utah
city: Ogden
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city: Salt Lake City
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city: West Jordan
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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: 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.