Clinical trial NCT00911534: Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Official title: A Multicenter Randomized Double-Blind Study to Compare the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Keywords: Gastroesophageal Reflux Disease
GERD
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).


Eligibility criteria: KEY INCLUSION CRITERIA:

Male or female, ages 18 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy.

KEY EXCLUSION CRITERIA:

Subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal motility disorders, current or a history of Barrett's esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications), current or a history of Zollinger-Ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded.

Primary outcomes:
measure: Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
measure: Percentage of Participants With Complete Heartburn Relief
timeFrame: Week 2 and Week 4
measure: Time to Achieve First 24-Hour Period Without Heartburn
timeFrame: Baseline to Week 4
Locations:
city: Athens
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Merced
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Altamonte Springs
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Cape Coral
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Newnam
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Hagerstown
country: United States
state: Maryland
city: Hollywood
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Mexico
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Haddon Heights
country: United States
state: New Jersey
city: Ocean
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Great neck
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Pittsford
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Boone
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Greesnboro
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: Kinston
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Rutherford College
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Gallipolis
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Franklin
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Joshson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corsicana
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Laredo
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Overland Park
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: West Valley City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Christiansburg
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
Study officials:
affiliation: Eisai Inc.
name: Guillermo Rossiter, MD
role: STUDY_DIRECTOR
References: