Clinical trial NCT00658775: Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
erosive GERD
erosive esophagitis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 1069
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Detailed description: 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 (eGERD).

Eligibility 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 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).

Primary outcomes:
measure: Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
timeFrame: Baseline and Week 8
measure: Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Moline
country: United States
state: Illinois
city: Buenos Aires
country: Argentina
state: BUE
city: Buenos Aires
country: Argentina
state: BUE
city: Ciudad Autonoma de Bs. As.
country: Argentina
state: CBA
city: Ciudad Autonoma de Bs. As.
country: Argentina
state: CBA
city: Ciudad Autonoma de Bs. As.
country: Argentina
state: CBA
city: Rosario
country: Argentina
state: SFE
city: San Miguel de Tucuman
country: Argentina
state: TUC
city: La Plata
country: Argentina
city: Penrith
country: Australia
state: New South Wales
city: Caboolture
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Woodville
country: Australia
state: South Australia
city: Launceston
country: Australia
state: Tasmania
city: Ballarat
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Haskovo
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Barrie
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Providencia
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Osijek
country: Croatia
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Lyon Cedex 3
country: France
state: Lyonnais
city: Marseille
country: France
state: Provence
city: Saint-Quentin 2
country: France
city: Potsdam
country: Germany
state: BR
city: Freising
country: Germany
state: BY
city: Herne
country: Germany
state: NW
city: Muenster
country: Germany
state: NW
city: Ludwigshafen
country: Germany
state: RP
city: Mainz
country: Germany
state: RP
city: Dresden
country: Germany
state: SN
city: Wolmirstedt
country: Germany
state: ST
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Pecs
country: Hungary
city: Siofok
country: Hungary
city: Szekszard
country: Hungary
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Secunderabad
country: India
state: Andhra Pradesh
city: Vishakapatnam
country: India
state: Andhra Pradesh
city: New Delhi
country: India
state: Delhi
city: Bangalore
country: India
state: Karnataka
city: Mangalore
country: India
state: Karnataka
city: Cochin
country: India
state: Kerala
city: Ludhiana
country: India
state: Punjab
city: Chennai
country: India
state: Tamilnadu
city: Madurai
country: India
state: Tamilnadu
city: Balvi
country: Latvia
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
Study officials:
affiliation: Eisai Inc.
name: Yufang Lu
role: STUDY_DIRECTOR
References:
citation: Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.