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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00658528




Registration number
NCT00658528
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
2007-005570-32
Secondary ID [2] 0 0
E3810-G000-301
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, taken orally, once daily for 4-8 weeks.

Treatment: Drugs: Esomeprazole
Esomeprazole 40 mg capsule, taken orally, 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 - Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
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 - Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
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 - During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.
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 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).
Minimum age
18 Years
Maximum age
75 Years
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Five Dock
Recruitment hospital [2] 0 0
- Carina Heights
Recruitment hospital [3] 0 0
- Kippa Ring
Recruitment hospital [4] 0 0
- Box Hill
Recruitment hospital [5] 0 0
- Frankston
Recruitment hospital [6] 0 0
- Malvern
Recruitment postcode(s) [1] 0 0
2046 - Five Dock
Recruitment postcode(s) [2] 0 0
4152 - Carina Heights
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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
MEN
Country [5] 0 0
Argentina
State/province [5] 0 0
SFE
Country [6] 0 0
Argentina
State/province [6] 0 0
SJN
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Plovdiv
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Stara Zagora
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Varna
Country [11] 0 0
Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Newfoundland and Labrador
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Canada
State/province [15] 0 0
Saskatchewan
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
Chile
State/province [17] 0 0
Vioa del Mar
Country [18] 0 0
Croatia
State/province [18] 0 0
Rijeka
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Estonia
State/province [20] 0 0
Tartu
Country [21] 0 0
France
State/province [21] 0 0
Dieppe 76
Country [22] 0 0
France
State/province [22] 0 0
La Chaussee St. Victor 41
Country [23] 0 0
France
State/province [23] 0 0
Lyon Cedex 369
Country [24] 0 0
France
State/province [24] 0 0
Marseille 13
Country [25] 0 0
France
State/province [25] 0 0
Nice Cedex 36
Country [26] 0 0
Germany
State/province [26] 0 0
BE
Country [27] 0 0
Germany
State/province [27] 0 0
BW
Country [28] 0 0
Germany
State/province [28] 0 0
BY
Country [29] 0 0
Germany
State/province [29] 0 0
HE
Country [30] 0 0
Germany
State/province [30] 0 0
HH
Country [31] 0 0
Germany
State/province [31] 0 0
NW
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Dunaujvaros
Country [34] 0 0
Hungary
State/province [34] 0 0
Kisber
Country [35] 0 0
Hungary
State/province [35] 0 0
Miskolc
Country [36] 0 0
Hungary
State/province [36] 0 0
Nagykanizsa
Country [37] 0 0
Hungary
State/province [37] 0 0
Nyiregyhaza
Country [38] 0 0
Hungary
State/province [38] 0 0
Szentes
Country [39] 0 0
Hungary
State/province [39] 0 0
Veszprem
Country [40] 0 0
Hungary
State/province [40] 0 0
Zalaegerszeg
Country [41] 0 0
India
State/province [41] 0 0
Delhi
Country [42] 0 0
India
State/province [42] 0 0
Gujarat
Country [43] 0 0
India
State/province [43] 0 0
Karnataka
Country [44] 0 0
India
State/province [44] 0 0
Madhya Pradesh
Country [45] 0 0
India
State/province [45] 0 0
Maharashtra
Country [46] 0 0
India
State/province [46] 0 0
Punjab
Country [47] 0 0
India
State/province [47] 0 0
Rajasthan
Country [48] 0 0
India
State/province [48] 0 0
Uttar Pradesh
Country [49] 0 0
Latvia
State/province [49] 0 0
Riga

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 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).
Trial website
https://clinicaltrials.gov/show/NCT00658528
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yufang Lu, MD, PhD
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
Other publications