Clinical trial NCT00658528: 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: 1061
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 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).

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 ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

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 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).

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: Anaheim
country: United States
state: California
city: Isidro Casanova, La Matanza
country: Argentina
state: BUE
city: Ramos Mejia
country: Argentina
state: BUE
city: San Isidro
country: Argentina
state: BUE
city: Capital Federal
country: Argentina
state: CBA
city: Mendoza
country: Argentina
state: MEN
city: Rosario
country: Argentina
state: SFE
city: Rosario
country: Argentina
state: SFE
city: Rosario
country: Argentina
state: SFE
city: San Juan
country: Argentina
state: SJN
city: Five Dock
country: Australia
state: New South Wales
city: Carina Heights
country: Australia
state: Queensland
city: Kippa Ring
country: Australia
state: Queensland
city: Box Hill
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Malvern
country: Australia
state: Victoria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Saint John
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Guelph
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Quebec
country: Canada
city: Santiago
country: Chile
city: Vioa del Mar
country: Chile
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Tartu
country: Estonia
city: Dieppe 76
country: France
city: La Chaussee St. Victor 41
country: France
city: Lyon Cedex 369
country: France
city: Marseille 13
country: France
city: Nice Cedex 36
country: France
city: Berlin
country: Germany
state: BE
city: Berlin
country: Germany
state: BE
city: Mannheim
country: Germany
state: BW
city: Muenchen
country: Germany
state: BY
city: Dietzenbach
country: Germany
state: HE
city: Marburg
country: Germany
state: HE
city: Wiesbaden
country: Germany
state: HE
city: Hamburg
country: Germany
state: HH
city: Dortmund
country: Germany
state: NW
city: Lienen/Kattenve nne
country: Germany
state: NW
city: Muenster
country: Germany
state: NW
city: Budapest
country: Hungary
city: Dunaujvaros
country: Hungary
city: Kisber
country: Hungary
city: Miskolc
country: Hungary
city: Nagykanizsa
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szentes
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
city: New Delhi
country: India
state: Delhi
city: New Delhi
country: India
state: Delhi
city: New Delhi
country: India
state: Delhi
city: Ahmedabad
country: India
state: Gujarat
city: Manipal
country: India
state: Karnataka
city: Bhopal
country: India
state: Madhya Pradesh
city: Aurangabad
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Nagpur
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Thane
country: India
state: Maharashtra
city: Ludhiana
country: India
state: Punjab
city: Jaipur
country: India
state: Rajasthan
city: Jaipur
country: India
state: Rajasthan
city: Lucknow
country: India
state: Uttar Pradesh
city: Riga
country: Latvia
city: Riga
country: Latvia
Study officials:
affiliation: Eisai Inc.
name: Yufang Lu, MD, PhD
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.