Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

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)

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).

Study Overview

• Status: Completed
• Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
• Intervention / Treatment: Drug: rabeprazole sodium; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35611
    • Huntsville, Alabama, United States, 35801
  • Arizona
    • Tucson, Arizona, United States, 85712
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • California
    • Anaheim, California, United States, 92801
    • Encinitas, California, United States, 92024
    • Irvine, California, United States, 92618
    • Lancaster, California, United States, 93534
    • Los Angeles, California, United States, 90301
    • Merced, California, United States, 95340
    • Oceanside, California, United States, 92056
    • Orange, California, United States, 92869
    • Pasadena, California, United States, 91105
    • Sacramento, California, United States, 95823
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92123
    • San Diego, California, United States, 92117
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
  • Connecticut
    • Bridgeport, Connecticut, United States, 6606
  • Florida
    • Altamonte Springs, Florida, United States, 32701
    • Boynton Beach, Florida, United States, 33437
    • Cape Coral, Florida, United States, 33904
    • Hialeah, Florida, United States, 33012
    • Miami, Florida, United States, 33144
    • Miami, Florida, United States, 33143
    • Miami, Florida, United States, 33133
    • New Smyrna Beach, Florida, United States, 32168
    • Orlando, Florida, United States, 32806
    • Tampa, Florida, United States, 33613
    • Wellington, Florida, United States, 33414
    • Zephyrhills, Florida, United States, 33542
  • Georgia
    • Decatur, Georgia, United States, 30033
    • Newnam, Georgia, United States, 30263
  • Illinois
    • Chicago, Illinois, United States, 60622
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Kansas
    • Wichita, Kansas, United States, 67207
    • Wichita, Kansas, United States, 67203
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
    • Metairie, Louisiana, United States, 70006
    • Shreveport, Louisiana, United States, 71103
  • Maryland
    • Hagerstown, Maryland, United States, 21742
    • Hollywood, Maryland, United States, 20636
  • Michigan
    • Chesterfield, Michigan, United States, 48047
    • Troy, Michigan, United States, 48098
  • Minnesota
    • Chaska, Minnesota, United States, 55318
  • Missouri
    • Mexico, Missouri, United States, 65265
  • Montana
    • Butte, Montana, United States, 59701
  • New Jersey
    • Haddon Heights, New Jersey, United States, 8035
    • Ocean, New Jersey, United States, 7712
    • Vineland, New Jersey, United States, 8360
    • Voorhees, New Jersey, United States, 8043
  • New York
    • Great Neck, New York, United States, 11023
    • Great neck, New York, United States, 11021
    • Lake Success, New York, United States, 11042
    • Pittsford, New York, United States, 14534
    • Rochester, New York, United States, 14609
  • North Carolina
    • Asheville, North Carolina, United States, 28801
    • Boone, North Carolina, United States, 28607
    • Charlotte, North Carolina, United States, 28209
    • Durham, North Carolina, United States, 277'13
    • Fayetteville, North Carolina, United States, 28304
    • Greesnboro, North Carolina, United States, 27265
    • High Point, North Carolina, United States, 27262
    • Jacksonville, North Carolina, United States, 28546
    • Kinston, North Carolina, United States, 28501
    • New Bern, North Carolina, United States, 28562
    • Raleigh, North Carolina, United States, 27612
    • Rutherford College, North Carolina, United States, 28671
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Gallipolis, Ohio, United States, 45631
    • Mentor, Ohio, United States, 44060
    • Perrysburg, Ohio, United States, 43551
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
    • Oklahoma City, Oklahoma, United States, 73112
  • South Carolina
    • Charleston, South Carolina, United States, 29414
    • Simpsonville, South Carolina, United States, 29681
  • Tennessee
    • Franklin, Tennessee, United States, 37067
    • Jackson, Tennessee, United States, 38301
    • Johnson City, Tennessee, United States, 37604
    • Joshson City, Tennessee, United States, 37601
    • Nashville, Tennessee, United States, 37203
    • Nashville, Tennessee, United States, 37211
  • Texas
    • Corsicana, Texas, United States, 75110
    • Houston, Texas, United States, 77030
    • Houston, Texas, United States, 77090
    • Laredo, Texas, United States, 78041
    • Odessa, Texas, United States, 79761
    • Overland Park, Texas, United States, 66215
    • San Antonio, Texas, United States, 78229
    • Sugar Land, Texas, United States, 77479
  • Utah
    • Bountiful, Utah, United States, 84010
    • Ogden, Utah, United States, 84405
    • West Valley City, Utah, United States, 84120
  • Virginia
    • Charlottesville, Virginia, United States, 22911
    • Christiansburg, Virginia, United States, 24073
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
    • Milwaukee, Wisconsin, United States, 53209
    • Monroe, Wisconsin, United States, 53566

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: rabeprazole sodium; One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.; Other Names: rabeprazole sodium extended release
Placebo Comparator: 2	Drug: Placebo; One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4	Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4	Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.	Baseline and Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Heartburn Relief	Participants completed a daily symptom diary.	Week 2 and Week 4
Time to Achieve First 24-Hour Period Without Heartburn	Participants completed a daily symptom diary.	Baseline to Week 4

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Guillermo Rossiter, MD, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Estimate): February 2, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: GERD; Gastroesophageal Reflux Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-A001-307