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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00658775




Registration number
NCT00658775
Ethics application status
Date submitted
9/04/2008
Date registered
15/04/2008
Date last updated
21/12/2015

Titles & IDs
Public title
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Scientific 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)
Secondary ID [1] 0 0
2007-006046-17
Secondary ID [2] 0 0
E3810-G000-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease (GERD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rabeprazole sodium
Treatment: Drugs - Esomeprazole

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.

Treatment: Drugs: Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Timepoint [1] 0 0
Baseline and Week 8
Primary outcome [2] 0 0
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Timepoint [2] 0 0
Baseline and Week 4
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Timepoint [1] 0 0
Week 4

Eligibility
Key inclusion 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
1069
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
- Penrith
Recruitment hospital [2] 0 0
- Caboolture
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Woodville
Recruitment hospital [5] 0 0
- Launceston
Recruitment hospital [6] 0 0
- Ballarat
Recruitment hospital [7] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
2751 - Penrith
Recruitment postcode(s) [2] 0 0
4510 - Caboolture
Recruitment postcode(s) [3] 0 0
5001 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3353 - Ballarat
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
Argentina
State/province [2] 0 0
BUE
Country [3] 0 0
Argentina
State/province [3] 0 0
CBA
Country [4] 0 0
Argentina
State/province [4] 0 0
SFE
Country [5] 0 0
Argentina
State/province [5] 0 0
TUC
Country [6] 0 0
Argentina
State/province [6] 0 0
La Plata
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Haskovo
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Plovdiv
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Rousse
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan
Country [14] 0 0
Chile
State/province [14] 0 0
Providencia
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Chile
State/province [16] 0 0
Temuco
Country [17] 0 0
Croatia
State/province [17] 0 0
Osijek
Country [18] 0 0
Croatia
State/province [18] 0 0
Split
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Estonia
State/province [20] 0 0
Tallinn
Country [21] 0 0
France
State/province [21] 0 0
Lyonnais
Country [22] 0 0
France
State/province [22] 0 0
Provence
Country [23] 0 0
France
State/province [23] 0 0
Saint-Quentin 2
Country [24] 0 0
Germany
State/province [24] 0 0
BR
Country [25] 0 0
Germany
State/province [25] 0 0
BY
Country [26] 0 0
Germany
State/province [26] 0 0
NW
Country [27] 0 0
Germany
State/province [27] 0 0
RP
Country [28] 0 0
Germany
State/province [28] 0 0
SN
Country [29] 0 0
Germany
State/province [29] 0 0
ST
Country [30] 0 0
Hungary
State/province [30] 0 0
Balatonfured
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Eger
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyor
Country [35] 0 0
Hungary
State/province [35] 0 0
Gyula
Country [36] 0 0
Hungary
State/province [36] 0 0
Kaposvar
Country [37] 0 0
Hungary
State/province [37] 0 0
Pecs
Country [38] 0 0
Hungary
State/province [38] 0 0
Siofok
Country [39] 0 0
Hungary
State/province [39] 0 0
Szekszard
Country [40] 0 0
India
State/province [40] 0 0
Andhra Pradesh
Country [41] 0 0
India
State/province [41] 0 0
Delhi
Country [42] 0 0
India
State/province [42] 0 0
Karnataka
Country [43] 0 0
India
State/province [43] 0 0
Kerala
Country [44] 0 0
India
State/province [44] 0 0
Punjab
Country [45] 0 0
India
State/province [45] 0 0
Tamilnadu
Country [46] 0 0
Latvia
State/province [46] 0 0
Balvi
Country [47] 0 0
Latvia
State/province [47] 0 0
Daugavpils
Country [48] 0 0
Latvia
State/province [48] 0 0
Riga
Country [49] 0 0
Lithuania
State/province [49] 0 0
Siauliai
Country [50] 0 0
Lithuania
State/province [50] 0 0
Vilnius

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00658775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yufang Lu
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00658775