Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)

Intervention: Rabeprazole sodium (Drug); Esomeprazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eisai Medical Research Inc.

Official(s) and/or principal investigator(s):
Yufang Lu, Study Director, Affiliation: Eisai Medical Research Inc.

Overall contact:
Eisai Medical Research Inc., Phone: 1-201-403-2500

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).

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Upper GI esophagogastroduodenoscopy (EGD), symptoms based on subject's daily diary and investigator's assessment.

Secondary outcome: Adverse events, electrocardiograms (ECGs), lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical exams, vital signs.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.

2. History of 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).

Eisai Medical Research Inc., Phone: 1-201-403-2500

Bydgoszcz 85-168, Poland; Not yet recruiting

Huntsville, Alabama 35801, United States; Recruiting

Huntsville, Alabama 35802, United States; Recruiting

Athens, Alabama 35611, United States; Not yet recruiting

Tucson, Arizona 85741, United States; Recruiting

Tucson, Arizona 85712, United States; Recruiting

Little Rock, Arkansas 72205, United States; Recruiting

Sherwood, Arkansas 72120, United States; Recruiting

Jonesboro, Arkansas 72401, United States; Not yet recruiting

Anaheim, California 92801, United States; Recruiting

Irvine, California 92618, United States; Recruiting

Laguna Hills, California 92653, United States; Recruiting

Mission Hills, California 91345, United States; Recruiting

Redwood, California 94062, United States; Recruiting

Chula Vista, California 91910, United States; Recruiting

San Diego, California 92123, United States; Recruiting

San Louis Obispo, California 93405, United States; Not yet recruiting

Fullerton, California 92835, United States; Not yet recruiting

West Covina, California 91790, United States; Recruiting

Carmichael, California 95608, United States; Recruiting

Sacramento, California 95825, United States; Not yet recruiting

Merced, California 95340, United States; Not yet recruiting

Los Angeles, California 90095, United States; Not yet recruiting

San Diego, California 92120, United States; Not yet recruiting

San Diego, California 92117, United States; Not yet recruiting

Beverly Hills, California 90210, United States; Not yet recruiting

Garden Grove, California 92840, United States; Not yet recruiting

San Carlos, California 94070, United States; Not yet recruiting

San Diego, California 92103-6204, United States; Recruiting

Wheat Ridge, Colorado 80033, United States; Recruiting

Pueblo, Colorado 81008, United States; Recruiting

Lafayette, Colorado 80026, United States; Recruiting

Littleton, Colorado 80120, United States; Not yet recruiting

Bristol, Connecticut 06010, United States; Recruiting

Hartford, Connecticut 06102, United States; Not yet recruiting

Hialeah, Florida 33010, United States; Recruiting

Boynton Beach, Florida 33426, United States; Recruiting

Hollywood, Florida 33021, United States; Recruiting

Lauderdale Lakes, Florida 33319, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Tampa, Florida 33613, United States; Recruiting

Largo, Florida 33777, United States; Recruiting

Jupiter, Florida 33458, United States; Recruiting

Jacksonville, Florida 32256, United States; Not yet recruiting

Naples, Florida 34102, United States; Not yet recruiting

Tampa, Florida 33607, United States; Not yet recruiting

Tampa, Florida 33618, United States; Recruiting

Lakeland, Florida 33805, United States; Not yet recruiting

Deerfield Beach, Florida 33442, United States; Not yet recruiting

Hialeah, Florida 33012, United States; Recruiting

Wellington, Florida 33414, United States; Recruiting

Cape Coral, Florida 33904, United States; Not yet recruiting

Miami, Florida 33126, United States; Not yet recruiting

Maitland, Florida 32701, United States; Not yet recruiting

Jacksonville, Florida 32207, United States; Not yet recruiting

Hialeah, Florida 33016, United States; Not yet recruiting

Miami, Florida 33133, United States; Recruiting

Newnan, Georgia 30263, United States; Recruiting

Atlanta, Georgia 30308, United States; Not yet recruiting

Augusta, Georgia 30912, United States; Not yet recruiting

Decatur, Georgia 30033, United States; Not yet recruiting

Canton, Georgia 30114, United States; Not yet recruiting

Tucker, Georgia 30084, United States; Recruiting

Conyers, Georgia 30013, United States; Recruiting

Boise, Idaho 83704, United States; Not yet recruiting

Rockford, Illinois 61107, United States; Recruiting

Evansville, Indiana 47714, United States; Not yet recruiting

Clive, Iowa 50325, United States; Recruiting

Topeka, Kansas 66606, United States; Recruiting

Kansas City, Kansas 66160, United States; Not yet recruiting

Salina, Kansas 67401, United States; Not yet recruiting

Overland Park, Kansas 66215, United States; Not yet recruiting

Wichita, Kansas 67214, United States; Not yet recruiting

Louisville, Kentucky 40291, United States; Not yet recruiting

Louisville, Kentucky 40202, United States; Not yet recruiting

Paducah, Kentucky 42003, United States; Recruiting

Lexington, Kentucky 40536, United States; Not yet recruiting

Baton Rouge, Louisiana 70809, United States; Recruiting

Slidell, Louisiana 70458, United States; Not yet recruiting

Annapolis, Maryland 21401, United States; Recruiting

Hagerstown, Maryland 21742, United States; Not yet recruiting

Laurel, Maryland 20707, United States; Recruiting

College Park, Maryland 20740, United States; Not yet recruiting

Wyoming, Michigan 49519, United States; Not yet recruiting

Chaska, Minnesota 55318, United States; Not yet recruiting

Washington, Missouri 63090, United States; Recruiting

Mexico, Missouri 65265, United States; Recruiting

Poplar Bluff, Missouri 63901, United States; Recruiting

Lebanon, New Hampshire 03756, United States; Not yet recruiting

Vineland, New Jersey 08360, United States; Not yet recruiting

Ocean, New Jersey 07712, United States; Recruiting

West Caldwell, New Jersey 07006, United States; Not yet recruiting

Albuquerque, New Mexico 87106, United States; Not yet recruiting

Hartsdale, New York 10530, United States; Not yet recruiting

Mineola, New York 11501, United States; Recruiting

New York, New York 10021, United States; Not yet recruiting

Bayshore, New York 11706, United States; Recruiting

Pittsford, New York 14534, United States; Not yet recruiting

New York, New York 10016, United States; Not yet recruiting

Brooklyn, New York 11218, United States; Not yet recruiting

Merrick, New York 11566, United States; Not yet recruiting

Troy, New York 12180, United States; Not yet recruiting

Jacksonville, North Carolina 28546, United States; Recruiting

Wilmington, North Carolina 28401, United States; Recruiting

Charlotte, North Carolina 28209, United States; Not yet recruiting

New Bern, North Carolina 28562, United States; Recruiting

Chapel Hill, North Carolina 27599, United States; Not yet recruiting

Boone, North Carolina 28607, United States; Recruiting

Fayettville, North Carolina 28304, United States; Recruiting

Raleigh, North Carolina 27607, United States; Not yet recruiting

Kinston, North Carolina 28501, United States; Recruiting

Greensboro, North Carolina 27408, United States; Not yet recruiting

Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Raleigh, North Carolina 27612, United States; Not yet recruiting

Morganton, North Carolina 28655, United States; Recruiting

Fargo, North Dakota 58104, United States; Not yet recruiting

Dayton, Ohio 45415, United States; Not yet recruiting

Mentor, Ohio 44060, United States; Recruiting

Gallipolis, Ohio 45631, United States; Not yet recruiting

Cincinnati, Ohio 45219, United States; Not yet recruiting

Columbus, Ohio 43210, United States; Not yet recruiting

Oklahoma City, Oklahoma 73112, United States; Not yet recruiting

Yukon, Oklahoma 73099, United States; Not yet recruiting

Portland, Oregon 97225, United States; Not yet recruiting

Portland, Oregon 97210, United States; Recruiting

Portland, Oregon 97220, United States; Not yet recruiting

Corvallis, Oregon 97330, United States; Not yet recruiting

Pottstown, Pennsylvania 19464, United States; Not yet recruiting

Hanover, Pennsylvania 17331, United States; Not yet recruiting

Charleston, South Carolina 29414, United States; Not yet recruiting

Columbia, South Carolina 29203, United States; Recruiting

Anderson, South Carolina 29621, United States; Recruiting

Manning, South Carolina 29102, United States; Not yet recruiting

Charleston, South Carolina 29412, United States; Not yet recruiting

Franklin, Tennessee 37067, United States; Recruiting

Nashville, Tennessee 37211, United States; Recruiting

Germantown, Tennessee 38138, United States; Recruiting

Nashville, Tennessee 37203, United States; Not yet recruiting

Johnson City, Tennessee 37604, United States; Recruiting

Jackson, Tennessee 38301, United States; Recruiting

Kingsport, Tennessee 37660, United States; Not yet recruiting

Nashville, Tennessee 37205, United States; Not yet recruiting

Chattanooga, Tennessee 37404, United States; Not yet recruiting

Houston, Texas 77079, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Dallas, Texas 75231, United States; Not yet recruiting

Bryan, Texas 77802, United States; Recruiting

Beaumont, Texas 77701, United States; Recruiting

Fort Worth, Texas 76104, United States; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

Pasadena, Texas 77504, United States; Not yet recruiting

Dallas, Texas 75390, United States; Not yet recruiting

Houston, Texas 77004, United States; Not yet recruiting

San Antonio, Texas 78215, United States; Not yet recruiting

Temple, Texas 76502, United States; Not yet recruiting

Laredo, Texas 78041, United States; Recruiting

Fort Worth, Texas 76107, United States; Recruiting

Sandy, Utah 64094, United States; Not yet recruiting

Salt Lake City, Utah 84107, United States; Not yet recruiting

Bountiful, Utah 84010, United States; Not yet recruiting

South Ogden, Utah 84405, United States; Not yet recruiting

Chesapeake, Virginia 23320, United States; Recruiting

Ettrick, Virginia 23803, United States; Not yet recruiting

Christainsburg, Virginia 24073, United States; Not yet recruiting

Charlottesville, Virginia 22911, United States; Not yet recruiting

Bellevue, Washington 98004, United States; Not yet recruiting

Spokane, Washington 99216, United States; Recruiting

Spokane, Washington 92204-2318, United States; Recruiting

Wenatchee, Washington 98801, United States; Recruiting

Milwaukee, Wisconsin 53209, United States; Not yet recruiting

Madison, Wisconsin 53715, United States; Not yet recruiting

Milwaukee, Wisconsin 53215, United States; Not yet recruiting

Monroe, Wisconsin 53566, United States; Recruiting

Milwaukee, Wisconsin 53233, United States; Not yet recruiting

Starting date: February 2008
Last updated: November 18, 2008