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Maintenance Intermittent Therapy for Symptomatic GERD Patients

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: NCT00165841
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : December 3, 2009
Last Update Posted : May 20, 2013
Sponsor:
Information provided by:
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Gastroesophageal Reflux Disease
Intervention Drug: Rabeprazole 20 mg
Enrollment 200
Recruitment Details This study was recruited at 47 centers in the US during the period of 7-Oct-2004 and 12-Dec-2005.
Pre-assignment Details After enrollment and before randomization (treatment assignment), there was a 2-week placebo run-in phase followed by a 4-week open-label Acute Phase during which subjects were treated with rabeprazole 20 mg once daily for the treatment of heartburn. Note the below participant flow is based on Safety Population (total 200 subjects).
Arm/Group Title Rabeprazole 20 mg Placebo
Hide Arm/Group Description Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
Period Title: Overall Study
Started 103 97
Completed 73 35
Not Completed 30 62
Reason Not Completed
Adverse Event             2             3
Lack of Efficacy             6             33
Lost to Follow-up             4             4
Withdrawal by Subject             7             8
Physician Decision             1             0
Protocol Violation             6             8
Other             3             5
Medication Noncompliance             1             1
Arm/Group Title Rabeprazole 20 mg Placebo Total
Hide Arm/Group Description Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population). Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population). Total of all reporting groups
Overall Number of Baseline Participants 96 91 187
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 91 participants 187 participants
46.0  (11.67) 46.6  (11.69) 46.3  (11.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 91 participants 187 participants
Female
64
  66.7%
59
  64.8%
123
  65.8%
Male
32
  33.3%
32
  35.2%
64
  34.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 91 participants 187 participants
American Indian or Alaska Native
0
   0.0%
1
   1.1%
1
   0.5%
Asian
1
   1.0%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   9.4%
10
  11.0%
19
  10.2%
White
74
  77.1%
64
  70.3%
138
  73.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
  12.5%
16
  17.6%
28
  15.0%
1.Primary Outcome
Title The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).
Hide Description The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.
Time Frame 6 months double-blind maintenance phase
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.
Arm/Group Title Rabeprazole 20 mg Placebo
Hide Arm/Group Description:
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
Overall Number of Participants Analyzed 96 91
Mean (Standard Deviation)
Unit of Measure: Percentage of Days
82.58  (14.39) 62.17  (29.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rabeprazole 20 mg, Placebo
Comments Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value was adjusted for multiple comparisons.
Method t-test, 2 sided
Comments The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.
2.Secondary Outcome
Title The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase
Hide Description The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase
Time Frame 6-month maintenance phase
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase
Hide Description The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month
Time Frame 6-month maintenance phase
Outcome Measure Data Not Reported
Time Frame 6 month maintenance phase
Adverse Event Reporting Description Safety population (total 200 subjects) was used for safety analysis and participant flow.
 
Arm/Group Title Rabeprazole 20 mg Placebo
Hide Arm/Group Description Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
All-Cause Mortality
Rabeprazole 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rabeprazole 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      2    
Gastrointestinal disorders     
Gallstone pancreatitis *  0/103 (0.00%)  0 1/97 (1.03%)  1
General disorders     
Chest pain *  1/103 (0.97%)  1 0/97 (0.00%)  0
Infections and infestations     
Pneumonia *  0/103 (0.00%)  0 1/97 (1.03%)  1
Nervous system disorders     
Schizoaffective disorder/depression *  1/103 (0.97%)  1 0/97 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Rabeprazole 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38      36    
Gastrointestinal disorders     
Diarrhea *  7/103 (6.80%)  1/97 (1.03%) 
Erosive gastritis *  2/103 (1.94%)  4/97 (4.12%) 
Hiatus hernia *  6/103 (5.83%)  4/97 (4.12%) 
Nausea *  5/103 (4.85%)  3/97 (3.09%) 
Esophageal erosion *  2/103 (1.94%)  6/97 (6.19%) 
Esophagitis *  4/103 (3.88%)  5/97 (5.15%) 
Infections and infestations     
Viral gastroenteritis *  0/103 (0.00%)  4/97 (4.12%) 
Sinusitis *  2/103 (1.94%)  4/97 (4.12%) 
Nervous system disorders     
Headache *  5/103 (4.85%)  3/97 (3.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  5/103 (4.85%)  2/97 (2.06%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Yufang Lu, Study Director
Organization: Eisai Medical Research Inc.
Phone: 201-403-2500
Layout table for additonal information
Responsible Party: Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165841    
Other Study ID Numbers: E3810-A001-203
First Submitted: September 13, 2005
First Posted: September 14, 2005
Results First Submitted: August 18, 2009
Results First Posted: December 3, 2009
Last Update Posted: May 20, 2013