Clinical trial NCT00251758: Safety and Efficacy 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 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, multi-center, 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 (NCT00241745) and T-GD04-083 (this posting, 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
* 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
* 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
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

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: 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
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Maria
country: United States
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
country: United States
state: Delaware
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
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
country: United States
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
country: United States
state: Illinois
city: Springfield
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state: Illinois
city: Evansville
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state: Indiana
city: Indianapolis
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state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Kansas City
country: United States
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: 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_DIRECTOR
References: