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Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

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ClinicalTrials.gov Identifier: NCT01397448
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : October 23, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Interventions: Drug: E3810
Drug: Teprenone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rabeprazole 5 mg Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
Rabeprazole 10 mg Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
Teprenone 150 mg Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.

Participant Flow:   Overall Study
    Rabeprazole 5 mg   Rabeprazole 10 mg   Teprenone 150 mg
STARTED   156   157 [1]   158 
COMPLETED   138   142   140 
NOT COMPLETED   18   15   18 
Adverse Event                4                4                6 
Withdrawal by Subject                4                4                3 
Lack of Efficacy                2                0                5 
Not specified                8                7                4 
[1] 158 participants were randomized but 1 participant was not treated with drug.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rabeprazole 5 mg Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
Rabeprazole 10 mg Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
Teprenone 150 mg Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
Total Total of all reporting groups

Baseline Measures
   Rabeprazole 5 mg   Rabeprazole 10 mg   Teprenone 150 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   157   158   471 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.3  (8.9)   70.1  (9.6)   69.4  (7.9)   69.6  (8.8) 
Gender 
[Units: Participants]
       
Female   35   36   41   112 
Male   121   121   117   359 
Antiplatelet Drug or Anticoagulant Drug 
[Units: Participants]
       
Yes   30   34   35   99 
No   126   123   123   372 
Daily Dose of Low-Dose Aspirin 
[Units: Participants]
       
81 mg   12   14   16   42 
100 mg   144   143   142   429 
Diagnostic Test of H.pylori. (IgG Antibody) 
[Units: Participants]
       
Positive   72   67   77   216 
Negative   84   90   81   255 
Primary Disease [1] 
[Units: Participants]
       
Angina Pectoris (Yes)   68   63   66   197 
Angina Pectoris (No)   88   94   92   274 
Myocardial Infarction (Yes)   27   31   33   91 
Myocardial Infarction (No)   129   126   125   380 
Ischemic Cerebrovascular Disease (Yes)   79   77   78   234 
Ischemic Cerebrovascular Disease (No)   77   80   80   237 
Coronary Arterial Bypass Grafting or PTCA (Yes)   52   51   48   151 
Coronary Arterial Bypass Grafting or PTCA (No)   104   106   110   320 
Other (Yes)   6   10   9   25 
Other (No)   150   147   149   446 
[1] Percutaneous Transluminal Coronary Angioplasty is represented as PTCA.


  Outcome Measures

1.  Primary:   Cumulative Recurrent Rates of Gastric or Duodenal Ulcers   [ Time Frame: 24 weeks ]

2.  Secondary:   Cumulative Incidence of Bleeding Ulcers   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nobuyuki Sugisaki
Organization: Eisai Co., Ltd.
phone: +81-3-3817-3908 ext 3908



Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01397448     History of Changes
Other Study ID Numbers: E3810-J081-308
First Submitted: July 18, 2011
First Posted: July 19, 2011
Results First Submitted: October 20, 2014
Results First Posted: October 23, 2014
Last Update Posted: November 26, 2014