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

NCT00911534 | Completed Phase 3 Results

• 1 other identifier: E3810-A001-307
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 98

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).

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Keywords

Gastroesophageal Reflux Disease; GERD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4

  Baseline and Week 4

Other Outcomes (2)

• Percentage of Participants With Complete Heartburn Relief

  Week 2 and Week 4

• Time to Achieve First 24-Hour Period Without Heartburn

  Baseline to Week 4

Study Arms (2)

1

EXPERIMENTAL

Drug: rabeprazole sodium

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

rabeprazole sodium DRUG

One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.

Also known as: rabeprazole sodium extended release

1

Placebo DRUG

One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (98)

Unknown Facility

Athens, Alabama, 35611, United States

Location

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Encinitas, California, 92024, United States

Location

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

Lancaster, California, 93534, United States

Location

Unknown Facility

Los Angeles, California, 90301, United States

Location

Unknown Facility

Merced, California, 95340, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Orange, California, 92869, United States

Location

Unknown Facility

Pasadena, California, 91105, United States

Location

Unknown Facility

Sacramento, California, 95823, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

San Diego, California, 92117, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

Wheat Ridge, Colorado, 80033, United States

Location

Unknown Facility

Bridgeport, Connecticut, 6606, United States

Location

Unknown Facility

Altamonte Springs, Florida, 32701, United States

Location

Unknown Facility

Boynton Beach, Florida, 33437, United States

Location

Unknown Facility

Cape Coral, Florida, 33904, United States

Location

Unknown Facility

Hialeah, Florida, 33012, United States

Location

Unknown Facility

Miami, Florida, 33133, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Miami, Florida, 33144, United States

Location

Unknown Facility

New Smyrna Beach, Florida, 32168, United States

Location

Unknown Facility

Orlando, Florida, 32806, United States

Location

Unknown Facility

Tampa, Florida, 33613, United States

Location

Unknown Facility

Wellington, Florida, 33414, United States

Location

Unknown Facility

Zephyrhills, Florida, 33542, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Newnam, Georgia, 30263, United States

Location

Unknown Facility

Chicago, Illinois, 60622, United States

Location

Unknown Facility

Evansville, Indiana, 47714, United States

Location

Unknown Facility

Wichita, Kansas, 67203, United States

Location

Unknown Facility

Wichita, Kansas, 67207, United States

Location

Unknown Facility

Lake Charles, Louisiana, 70601, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Shreveport, Louisiana, 71103, United States

Location

Unknown Facility

Hagerstown, Maryland, 21742, United States

Location

Unknown Facility

Hollywood, Maryland, 20636, United States

Location

Unknown Facility

Chesterfield, Michigan, 48047, United States

Location

Unknown Facility

Troy, Michigan, 48098, United States

Location

Unknown Facility

Chaska, Minnesota, 55318, United States

Location

Unknown Facility

Mexico, Missouri, 65265, United States

Location

Unknown Facility

Butte, Montana, 59701, United States

Location

Unknown Facility

Haddon Heights, New Jersey, 8035, United States

Location

Unknown Facility

Ocean City, New Jersey, 7712, United States

Location

Unknown Facility

Vineland, New Jersey, 8360, United States

Location

Unknown Facility

Voorhees Township, New Jersey, 8043, United States

Location

Unknown Facility

Great Neck, New York, 11021, United States

Location

Unknown Facility

Great Neck, New York, 11023, United States

Location

Unknown Facility

Lake Success, New York, 11042, United States

Location

Unknown Facility

Pittsford, New York, 14534, United States

Location

Unknown Facility

Rochester, New York, 14609, United States

Location

Unknown Facility

Asheville, North Carolina, 28801, United States

Location

Unknown Facility

Boone, North Carolina, 28607, United States

Location

Unknown Facility

Charlotte, North Carolina, 28209, United States

Location

Unknown Facility

Durham, North Carolina, 277'13, United States

Location

Unknown Facility

Fayetteville, North Carolina, 28304, United States

Location

Unknown Facility

Greesnboro, North Carolina, 27265, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Jacksonville, North Carolina, 28546, United States

Location

Unknown Facility

Kinston, North Carolina, 28501, United States

Location

Unknown Facility

New Bern, North Carolina, 28562, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Rutherford College, North Carolina, 28671, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Gallipolis, Ohio, 45631, United States

Location

Unknown Facility

Mentor, Ohio, 44060, United States

Location

Unknown Facility

Perrysburg, Ohio, 43551, United States

Location

Unknown Facility

Norman, Oklahoma, 73071, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Charleston, South Carolina, 29414, United States

Location

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

Unknown Facility

Franklin, Tennessee, 37067, United States

Location

Unknown Facility

Jackson, Tennessee, 38301, United States

Location

Unknown Facility

Johnson City, Tennessee, 37604, United States

Location

Unknown Facility

Joshson City, Tennessee, 37601, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Nashville, Tennessee, 37211, United States

Location

Unknown Facility

Corsicana, Texas, 75110, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, 77090, United States

Location

Unknown Facility

Laredo, Texas, 78041, United States

Location

Unknown Facility

Odessa, Texas, 79761, United States

Location

Unknown Facility

Overland Park, Texas, 66215, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Sugar Land, Texas, 77479, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

Unknown Facility

Ogden, Utah, 84405, United States

Location

Unknown Facility

West Valley City, Utah, 84120, United States

Location

Unknown Facility

Charlottesville, Virginia, 22911, United States

Location

Unknown Facility

Christiansburg, Virginia, 24073, United States

Location

Unknown Facility

Madison, Wisconsin, 53715, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53209, United States

Location

Unknown Facility

Monroe, Wisconsin, 53566, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Guillermo Rossiter, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 2, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 2, 2016
• Results First Posted: February 2, 2016

Record last verified: 2015-11

Locations

US (98)