Clinical trial NCT00658632: Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Official title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
erosive GERD
erosive esophagitis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 1397
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 investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

Detailed description: This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).

Eligibility criteria: KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.
2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom diary.

KEY EXCLUSION CRITERIA:

1. Current or a history of esophageal motility disorders.
2. 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).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).

Primary outcomes:
measure: Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
timeFrame: Baseline and Week 8
measure: Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Irvine
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Redwood
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Louis Obispo
country: United States
state: California
city: West Covina
country: United States
state: California
city: Pueblo
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Rockford
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Mexico
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Vineland
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bayshore
country: United States
state: New York
city: Hartsdale
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Pittsford
country: United States
state: New York
city: Boone
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Franklin
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: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Bryan
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: San Antonio
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Eisai Inc.
name: Yufang Lu
role: STUDY_DIRECTOR
References: