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 Medical Research Inc.

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

Overall contact:
Eisai Medical Research, Phone: 201403- 2550

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 moderate to severe 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), 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 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.

3. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).

4. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.

5. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.

6. Inflammatory bowel disease.

7. Unstable diabetes mellitus.

8. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.

9. 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: 201403- 2550

La Plata 1900, Argentina; Not yet recruiting

Plovdiv 4000, Bulgaria; Not yet recruiting

Sofia 1606, Bulgaria; Not yet recruiting

Rousse 7002, Bulgaria; Not yet recruiting

Sofia 1527, Bulgaria; Not yet recruiting

Haskovo 6300, Bulgaria; Not yet recruiting

Temuco, Chile; Not yet recruiting

Santiago, Chile; Not yet recruiting

Providencia, Chile; Not yet recruiting

Osijek 31 000, Croatia; Not yet recruiting

Split 21 000, Croatia; Not yet recruiting

Zagreb 10 000, Croatia; Not yet recruiting

Tallinn 10138, Estonia; Not yet recruiting

Tallinn 10617, Estonia; Not yet recruiting

Debrecen 4032, Hungary; Not yet recruiting

Budapest 1201, Hungary; Not yet recruiting

Kaposvar 7400, Hungary; Not yet recruiting

Pecs 7624, Hungary; Not yet recruiting

Balatonfured 8230, Hungary; Not yet recruiting

Budapest 1088, Hungary; Not yet recruiting

Siofok 8601, Hungary; Not yet recruiting

Gyula 5700, Hungary; Not yet recruiting

Gyor 9024, Hungary; Not yet recruiting

Eger 3300, Hungary; Not yet recruiting

Szekszard 7100, Hungary; Not yet recruiting

Daugavpils LV-5417, Latvia; Recruiting

Balvi LV-4501, Latvia; Recruiting

Riga LV-1006, Latvia; Not yet recruiting

Siauliai LT-76231, Lithuania; Recruiting

Vilnius LT-08661, Lithuania; Not yet recruiting

Vilnius 03215, Lithuania; Recruiting

Dunedin 9016, New Zealand; Recruiting

Auckland, New Zealand; Not yet recruiting

Krakow 31-351, Poland; Not yet recruiting

Warszawa 02-507, Poland; Recruiting

Szczecin 70-361, Poland; Not yet recruiting

Lublin 20-718, Poland; Not yet recruiting

Warszawa 02-097, Poland; Recruiting

Bydgoszcz 85-681, Poland; Recruiting

Poznan 60-693, Poland; Not yet recruiting

Moscow 119010, Russian Federation; Not yet recruiting

Moscow 107014, Russian Federation; Not yet recruiting

St. Petersburg 194291, Russian Federation; Not yet recruiting

St. Petersburg 195067, Russian Federation; Not yet recruiting

Moscow 129010, Russian Federation; Not yet recruiting

Moscow 105229, Russian Federation; Not yet recruiting

Moscow 127473, Russian Federation; Not yet recruiting

Moscow 121309, Russian Federation; Not yet recruiting

Yaroslavl 150010, Russian Federation; Not yet recruiting

Yaroslavl 150062, Russian Federation; Not yet recruiting

Barnaul 656038, Russian Federation; Not yet recruiting

Novosibirsk 630090, Russian Federation; Not yet recruiting

Zemun 11080, Serbia; Not yet recruiting

Belgrade 11000, Serbia; Not yet recruiting

Nis 18000, Serbia; Not yet recruiting

Povazska Bystrica 01726, Slovakia; Not yet recruiting

Nitra 94901, Slovakia; Not yet recruiting

Trnava 91700, Slovakia; Not yet recruiting

Bratislava 826 06, Slovakia; Not yet recruiting

Dnipropetrovsk 49074, Ukraine; Not yet recruiting

Lviv 79059, Ukraine; Not yet recruiting

Ivano-Frankovsk 76000, Ukraine; Not yet recruiting

Kyiv 02660, Ukraine; Not yet recruiting

Poltava 36024, Ukraine; Not yet recruiting

Kharkiv 61039, Ukraine; Not yet recruiting

Saint-Quentin, 02 02100, France; Not yet recruiting

Hyderabad, Andhra Pradesh 500012, India; Not yet recruiting

Hyderabad, Andhra Pradesh 500004, India; Recruiting

Hyderabad, Andhra Pradesh 500 082, India; Not yet recruiting

Hyderabad, Andhra Pradesh 500001, India; Not yet recruiting

Hyderabad, Andhra Pradesh 500082, India; Not yet recruiting

Secunderabad, Andhra Pradesh 500003, India; Not yet recruiting

Vishakapatnam, Andhra Pradesh 53002, India; Not yet recruiting

Hyderabad, Andhra Pradesh 500063, India; Not yet recruiting

Little Rock, Arkansas 72205, United States; Not yet recruiting

Potsdam, BR 14482, Germany; Not yet recruiting

Buenos Aires, BUE C1117ABK, Argentina; Not yet recruiting

Buenos Aires, BUE B1832BQS, Argentina; Not yet recruiting

Ciudad Autonoma de Bs. As., CBA C1120AAT, Argentina; Not yet recruiting

Ciudad Autonoma de Bs. As., CBA 1431, Argentina; Not yet recruiting

Ciudad Autonoma de Bs. As., CBA C1181ACH, Argentina; Not yet recruiting

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

Oceanside, California 92056, United States; Not yet recruiting

Orange, California 92869, United States; Not yet recruiting

Modesto, California 95355, United States; Not yet recruiting

Distrito Federal, DF 06760, Mexico; Not yet recruiting

New Delhi, Delhi 110029, India; Not yet recruiting

Toluca, EMEX 50180, Mexico; Not yet recruiting

Miami, Florida 33133, United States; Recruiting

Pinellas Park, Florida 33782, United States; Recruiting

Zephyrhills, Florida 33542, United States; Recruiting

Miami, Florida 33143, United States; Recruiting

Parktown, Gauteng 2193, South Africa; Not yet recruiting

Kemptonpark, Gauteng 1619, South Africa; Not yet recruiting

Florida, Gauteng 1709, South Africa; Not yet recruiting

Tucker, Georgia 30084, United States; Recruiting

Conyers, Georgia 30013, United States; Recruiting

Moline, Illinois 61265, United States; Recruiting

Chicago, Illinois 60622, United States; Not yet recruiting

Chicago, Illinois 60657, United States; Not yet recruiting

Zapopan, Jal 44200, Mexico; Not yet recruiting

Durban, KZ-Natal 4091, South Africa; Not yet recruiting

Bangalore, Karnataka 560054, India; Not yet recruiting

Mangalore, Karnataka 575001, India; Not yet recruiting

Cochin, Kerala 682304, India; Not yet recruiting

Metairie, Louisiana 70006, United States; Not yet recruiting

Meltairie, Louisiana 70006, United States; Not yet recruiting

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

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

Framingham, Massachusetts 01702, United States; Not yet recruiting

Chesterfield, Michigan 48047, United States; Not yet recruiting

Poplar Bluff, Missouri 63901, United States; Recruiting

Butte, Montana 59701, United States; Not yet recruiting

Monterrey, NL 64460, Mexico; Not yet recruiting

Herne, NW 44623, Germany; Not yet recruiting

Muenster, NW 48167, Germany; Not yet recruiting

Lincoln, Nebraska 68510, United States; Not yet recruiting

Hillsborough, New Jersey 08844, United States; Recruiting

Penrith, New South Wales 2751, Australia; Not yet recruiting

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

Rochester, New York 14609, United States; Not yet recruiting

Manhasset, New York 11030, United States; Not yet recruiting

Lake Success, New York 11042, United States; Recruiting

Great Neck, New York 11021, United States; Recruiting

Huntington Station, New York 11746, United States; Not yet recruiting

Port Jefferson Station, New York 11766, United States; Not yet recruiting

Lake Success, New York 11042, United States; Not yet recruiting

Morganton, North Carolina 28655, United States; Recruiting

Salisbury, North Carolina 28144, United States; Not yet recruiting

Harrisburg, North Carolina 28075, United States; Recruiting

Columbus, Ohio 43210, United States; Not yet recruiting

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

Yucon, Oklahoma 73099, United States; Not yet recruiting

Toronto, Ontario M9W 4L6, Canada; Not yet recruiting

Sarnia, Ontario N7T 4X3, Canada; Not yet recruiting

Richmond Hill, Ontario L4B 3P8, Canada; Recruiting

Toronto, Ontario M3N 2V7, Canada; Not yet recruiting

Chatham, Ontario N7L 1B9, Canada; Not yet recruiting

Barrie, Ontario L4M 7G1, Canada; Not yet recruiting

Hamilton, Ontario L8V 1C3, Canada; Not yet recruiting

Toronto, Ontario M3J 1N2, Canada; Not yet recruiting

Toronto, Ontario M4P 1P2, Canada; Not yet recruiting

Marseille, Provence 13015, France; Not yet recruiting

Ludhiana, Punjab 141001, India; Not yet recruiting

Sherbrooke, Quebec J1G 2E8, Canada; Not yet recruiting

Caboolture, Queensland 4510, Australia; Recruiting

Mainz, RP 55131, Germany; Not yet recruiting

Ludwigshafen, RP 67067, Germany; Not yet recruiting

Rosario, SFE 2000, Argentina; Not yet recruiting

Culiacan, SIN 80020, Mexico; Not yet recruiting

Dresden, SN 01307, Germany; Not yet recruiting

Wolmirstedt, ST 39326, Germany; Not yet recruiting

Saskatoon, Saskatchewan S7K 1N4, Canada; Not yet recruiting

Adelaide, South Australia 5001, Australia; Not yet recruiting

Woodville, South Australia 5011, Australia; Not yet recruiting

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

San Miguel de Tucuman, TUC 4000, Argentina; Not yet recruiting

Chennai, Tamilnadu 600096, India; Not yet recruiting

Madurai, Tamilnadu 625002, India; Not yet recruiting

Launceston, Tasmania 7250, Australia; Recruiting

Johnson City, Tennessee 37601, United States; Recruiting

Laredo, Texas 78041, United States; Not yet recruiting

Fort Worth, Texas 76107, United States; Recruiting

Houston, Texas 77024, United States; Not yet recruiting

Spring, Texas 77386, United States; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

Irving, Texas 75061, United States; Not yet recruiting

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

Fitzroy, Victoria 3065, Australia; Not yet recruiting

Ballarat, Victoria 3353, Australia; Not yet recruiting

Somerset West, Western Cape 7130, South Africa; Not yet recruiting

Cape Town, Western Cape 7463, South Africa; Not yet recruiting

Panorama, Western Cape 7500, South Africa; Not yet recruiting

Cape Town, Western Cape 7530, South Africa; Not yet recruiting

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

Merida, YUC 97070, Mexico; Not yet recruiting

Freising, by 85356, Germany; Not yet recruiting

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