Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe 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 Inc.

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

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

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with 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 Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

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

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

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

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

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 C or D 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, Phone: 1-201-403-2500

Sofia 1233, Bulgaria; Not yet recruiting

Varna 9010, Bulgaria; Not yet recruiting

Sofia 1709, Bulgaria; Not yet recruiting

Sofia 1431, Bulgaria; Not yet recruiting

Sofia 1407, Bulgaria; Not yet recruiting

Plovdiv 4000, Bulgaria; Not yet recruiting

Stara Zagora 6000, Bulgaria; Not yet recruiting

Quebec G1L 3L5, Canada; Not yet recruiting

Quebec G1R 2J6, Canada; Not yet recruiting

Santiago, Chile; Not yet recruiting

Vioa del Mar, Chile; Not yet recruiting

Zagreb 10 000, Croatia; Not yet recruiting

Rijeka 51 000, Croatia; Not yet recruiting

Tartu 51014, Estonia; Recruiting

Kisbr 2870, Hungary; Recruiting

Dunaujvaros 2400, Hungary; Not yet recruiting

Nagykanizsa 8800, Hungary; Not yet recruiting

Nyiregyhaza 4400, Hungary; Recruiting

Veszprem 8200, Hungary; Not yet recruiting

Zalaegerszeg 8900, Hungary; Not yet recruiting

Szentes 6600, Hungary; Not yet recruiting

Budapest 1036, Hungary; Not yet recruiting

Miskolc 3530, Hungary; Not yet recruiting

Riga LV-1005, Latvia; Recruiting

Riga LV-1002, Latvia; Recruiting

Riga LV-1001, Latvia; Recruiting

Riga LV-1038, Latvia; Not yet recruiting

Kaunas T-50009, Lithuania; Recruiting

Vilnius LT-10207, Lithuania; Recruiting

Auckland, New Zealand; Recruiting

Tauranga 3112, New Zealand; Not yet recruiting

Hamilton 3240, New Zealand; Not yet recruiting

Gdansk 80-462, Poland; Not yet recruiting

Sopot 81-756, Poland; Recruiting

Lodz 90-153, Poland; Not yet recruiting

Wroclaw 54-144, Poland; Recruiting

Torun 87-100, Poland; Not yet recruiting

Skierniewice 96-100, Poland; Not yet recruiting

St. Petersburg 197047, Russian Federation; Not yet recruiting

St. Petersburg 191025, Russian Federation; Not yet recruiting

Moscow 115446, Russian Federation; Not yet recruiting

St. Petersburg 194044, Russian Federation; Not yet recruiting

Sanct-Petersburg 194354, Russian Federation; Not yet recruiting

Moscow 111020, Russian Federation; Not yet recruiting

Moscow 117415, Russian Federation; Not yet recruiting

Moscow 123367, Russian Federation; Not yet recruiting

Ekaterinburg 620102, Russian Federation; Not yet recruiting

Novosibirsk 630003, Russian Federation; Not yet recruiting

Novosibirsk 630005, Russian Federation; Not yet recruiting

Belgrade 11000, Serbia; Not yet recruiting

Belgrade 11070, Serbia; Not yet recruiting

Sucany 03852, Slovakia; Not yet recruiting

Presov 08001, Slovakia; Not yet recruiting

Kosice 04001, Slovakia; Not yet recruiting

Bratislava 81107, Slovakia; Not yet recruiting

Kiev 01030, Ukraine; Not yet recruiting

Vinnitsa 21014, Ukraine; Not yet recruiting

Kiev 04201, Ukraine; Not yet recruiting

Simferopol, Crimea 95017, Ukraine; Not yet recruiting

Kharkiv 61037, Ukraine; Not yet recruiting

Kiev 01021, Ukraine; Not yet recruiting

Nice Cedex 3, 06 06100, France; Not yet recruiting

Marseille, 13 13009, France; Not yet recruiting

La Chaussee St Victor, 41 41260, France; Not yet recruiting

Lyon Cedex 3, 69 69437, France; Not yet recruiting

Dieppe, 76 76200, France; Not yet recruiting

Huntsville, Alabama 35801, United States; Recruiting

Little Rock, Arkansas 72205, United States; Recruiting

Sherwood, Arkansas 72120, United States; Recruiting

Berlin, BE 13509, Germany; Not yet recruiting

Berlin, BE 10967, Germany; Not yet recruiting

San Isidro, BUE B1642BHH, Argentina; Not yet recruiting

Ramos Mejia, BUE 1221, Argentina; Not yet recruiting

Isidro Casanova, La Matanza, BUE 1765, Argentina; Not yet recruiting

Mannheim, BW 68167, Germany; Not yet recruiting

Capital Federal, CBA C1425DND, Argentina; 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

Chihuahua, Chih 31000, Mexico; Not yet recruiting

Chihuahua, Chih 31238, Mexico; Not yet recruiting

Wheat Ridge, Colorado 80033, United States; Recruiting

Pueblo, Colorado 81008, United States; Recruiting

Mexico D.F., D.F. 14080, Mexico; Not yet recruiting

Distrito Federal, DF 14000, Mexico; Not yet recruiting

Durango, DGO 34000, Mexico; Not yet recruiting

New Delhi, Delhi 110017, India; Not yet recruiting

New Delhi, Delhi 110002, India; Not yet recruiting

New Delhi, Delhi 110 060, India; 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

Pretoria, Gauteng 0181, South Africa; Not yet recruiting

Pretoria, Gauteng 0040, South Africa; Not yet recruiting

Newnan, Georgia 30263, United States; Recruiting

Ahmedabad, Gujarat 380006, India; Not yet recruiting

Dietzenbach, HE 63128, Germany; Not yet recruiting

Marburg, HE 35033, Germany; Not yet recruiting

Wiesbaden, HE 65185, Germany; Not yet recruiting

Hamburg, HH 22143, Germany; Not yet recruiting

Rockford, Illinois 61107, United States; Recruiting

Glenwood, KZ-NATAL 4001, South Africa; Not yet recruiting

Amanzimtoti, KZ-NATAL 4125, South Africa; Not yet recruiting

Topeka, Kansas 66606, United States; Recruiting

Manipal, Karnataka 576104, India; Not yet recruiting

Louisville, Kentucky 40291, United States; Not yet recruiting

Louisville, Kentucky 40202, United States; Not yet recruiting

Baton Rouge, Louisiana 70809, United States; Recruiting

Mendoza, MEN 5500, Argentina; Not yet recruiting

Bhopal, Madhya Pradesh 462038, India; Not yet recruiting

Mumbai, Maharashtra 400016, India; Not yet recruiting

Mumbai, Maharashtra 400020, India; Not yet recruiting

Nagpur, Maharashtra 440012, India; Not yet recruiting

Mumbai, Maharashtra 400012, India; Not yet recruiting

Aurangabad, Maharashtra 431005, India; Not yet recruiting

Mumbai, Maharashtra 400 022, India; Not yet recruiting

Pune, Maharashtra 411001, India; Not yet recruiting

Pune, Maharashtra PUNE-411013, India; Recruiting

Pune, Maharashtra 411004, India; Not yet recruiting

Thane, Maharashtra 400001, India; Not yet recruiting

Annapolis, Maryland 21401, United States; Recruiting

Hagerstown, Maryland 21742, United States; Not yet recruiting

Washington, Missouri 63090, United States; Recruiting

Monterrey, NL 64000, Mexico; Not yet recruiting

Muenster, NW 48159, Germany; Not yet recruiting

Dortmund, NW 44137, Germany; Not yet recruiting

Lienen/Kattenvenne, NW 49536, Germany; Not yet recruiting

Saint John, New Brunswick E2K 1J5, Canada; Not yet recruiting

Five Dock, New South Wales 2046, Australia; 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; Recruiting

Bayshore, New York 11706, United States; Recruiting

St. John's, Newfoundland and Labrador A1A 3R5, Canada; Recruiting

Jacksonville, North Carolina 28546, United States; Recruiting

Wilmington, North Carolina 28401, United States; Recruiting

Charlotte, North Carolina 28209, United States; Recruiting

Hamilton, Ontario L8N 3Z5, Canada; Not yet recruiting

Newmarket, Ontario L3Y 5G8, Canada; Not yet recruiting

Guelph, Ontario N1H 3R3, Canada; Not yet recruiting

Windsor, Ontario N8W 1E6, Canada; Not yet recruiting

Toronto, Ontario M6H 3M1, Canada; Not yet recruiting

Portland, Oregon 97225, United States; Not yet recruiting

Ludhiana, Punjab 141008, India; Not yet recruiting

Montreal, Quebec H1T 2M4, Canada; Not yet recruiting

Pointe-Claire, Quebec H9R 3J1, Canada; Not yet recruiting

Montreal, Quebec H3A 1A1, Canada; Not yet recruiting

Kippa Ring, Queensland 4021, Australia; Recruiting

Carina Heights, Queensland 4152, Australia; Recruiting

Jaipur, Rajasthan 302001, India; Not yet recruiting

Jaipur, Rajasthan 302004, India; Not yet recruiting

Rosario, SFE S2000CVB, Argentina; Not yet recruiting

Rosario, SFE S2000CRF, Argentina; Not yet recruiting

Rosario, SFE S2000BLG, Argentina; Not yet recruiting

San Juan, SJN 5447, Argentina; Not yet recruiting

Saskatoon, Saskatchewan S7K 1J5, Canada; Recruiting

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

Columbia, South Carolina 29203, United States; Recruiting

Franklin, Tennessee 37067, United States; Recruiting

Nashville, Tennessee 37211, United States; 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

Lucknow, Uttar Pradesh 226003, India; Not yet recruiting

Malvern, Victoria 3144, Australia; Not yet recruiting

Box Hill, Victoria 3128, Australia; Not yet recruiting

Frankston, Victoria 3199, Australia; Not yet recruiting

Somerset West, Western Cape 7129, South Africa; Not yet recruiting

Cape Town, Western Cape 7800, South Africa; Not yet recruiting

Cape Town, Western Cape 7925, South Africa; Not yet recruiting

Claremont, Western Cape 7708, South Africa; Not yet recruiting

Muenchen, by 81669, Germany; Not yet recruiting

Starting date: February 2008
Last updated: August 27, 2009