Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658528
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : June 23, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux Disease (GERD)
Interventions Drug: Rabeprazole sodium
Drug: Esomeprazole
Enrollment 1061
Recruitment Details  
Pre-assignment Details Out of 1061 participants who were randomized, 1055 participants received study treatment.
Arm/Group Title ESO 40 mg RAB ER 50 mg
Hide Arm/Group Description Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks. Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
Period Title: Overall Study
Started 531 [1] 524 [1]
Completed 491 479
Not Completed 40 45
Reason Not Completed
Adverse Event             5             7
Lost to Follow-up             14             22
Withdrawal by Subject             8             6
Withdrawal of consent             5             6
Not specified             8             4
[1]
Treated
Arm/Group Title ESO 40 mg RAB ER 50 mg Total
Hide Arm/Group Description ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks. RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 531 524 1055
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 531 participants 524 participants 1055 participants
49  (13.09) 48  (13.38) 48.5  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 524 participants 1055 participants
Female
206
  38.8%
202
  38.5%
408
  38.7%
Male
325
  61.2%
322
  61.5%
647
  61.3%
1.Primary Outcome
Title Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Hide Description

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.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.
Arm/Group Title ESO 40 mg RAB ER 50 mg
Hide Arm/Group Description:
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
Overall Number of Participants Analyzed 531 524
Measure Type: Number
Unit of Measure: Percentage of Participants
Yes 75 80
No 20.3 14.9
Missing 4.7 5.2
2.Primary Outcome
Title Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Hide Description

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.

Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title ESO 40 mg RAB ER 50 mg
Hide Arm/Group Description:
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
Overall Number of Participants Analyzed 531 524
Measure Type: Number
Unit of Measure: Percentage of Participants
Yes 50.3 54.8
No 47.8 42.6
Missing 1.9 2.7
3.Secondary Outcome
Title Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Hide Description 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title ESO 40 mg RAB ER 50 mg
Hide Arm/Group Description:
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
Overall Number of Participants Analyzed 531 524
Measure Type: Number
Unit of Measure: Percentage of Participants
Yes 48.2 48.3
No 46.3 44.3
Missing 5.5 7.4
Time Frame For each participant, from the time of administartion of the first dose of study drug up to 30 days after the administration of the last dose of study drug or up to resolution of adverse event or up to approximately 10 weeks.
Adverse Event Reporting Description Data are presented as number of participants with treatment emergent adverse events (serious and non-serious). The analysis was performed using Safety Analysis Set (SAS) defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.
 
Arm/Group Title ESO 40 mg RAB ER 50 mg
Hide Arm/Group Description ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks. RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
All-Cause Mortality
ESO 40 mg RAB ER 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ESO 40 mg RAB ER 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/528 (0.76%)   4/518 (0.77%) 
Blood and lymphatic system disorders     
Anaemia  1  1/528 (0.19%)  0/518 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  0/528 (0.00%)  1/518 (0.19%) 
Atrial fibrillation  1  0/528 (0.00%)  1/518 (0.19%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/528 (0.00%)  1/518 (0.19%) 
Cholelithiasis  1  0/528 (0.00%)  1/518 (0.19%) 
Injury, poisoning and procedural complications     
Subdural haematoma  1  1/528 (0.19%)  0/518 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesophageal carcinoma  1  1/528 (0.19%)  0/518 (0.00%) 
Ovarian adenoma  1  1/528 (0.19%)  0/518 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  0/528 (0.00%)  1/518 (0.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ESO 40 mg RAB ER 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/528 (0.00%)   0/518 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00658528     History of Changes
Other Study ID Numbers: E3810-G000-301
2007-005570-32 ( EudraCT Number )
First Submitted: April 9, 2008
First Posted: April 15, 2008
Results First Submitted: June 8, 2015
Results First Posted: June 23, 2015
Last Update Posted: December 21, 2015