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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
Enrollment 472
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 156 157 [1] 158
Completed 138 142 140
Not Completed 18 15 18
Reason Not Completed
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.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 156 157 158 471
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 157 participants 158 participants 471 participants
69.3  (8.9) 70.1  (9.6) 69.4  (7.9) 69.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 158 participants 471 participants
Female
35
  22.4%
36
  22.9%
41
  25.9%
112
  23.8%
Male
121
  77.6%
121
  77.1%
117
  74.1%
359
  76.2%
Antiplatelet Drug or Anticoagulant Drug  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 158 participants 471 participants
Yes 30 34 35 99
No 126 123 123 372
Daily Dose of Low-Dose Aspirin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 158 participants 471 participants
81 mg 12 14 16 42
100 mg 144 143 142 429
Diagnostic Test of H.pylori. (IgG Antibody)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 158 participants 471 participants
Positive 72 67 77 216
Negative 84 90 81 255
Primary Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 158 participants 471 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]
Measure Description: Percutaneous Transluminal Coronary Angioplasty is represented as PTCA.
1.Primary Outcome
Title Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Hide Description Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 150 151 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events/100 participants/24 weeks
2.8
(1.04 to 7.17)
1.4
(0.35 to 5.51)
21.7
(15.84 to 29.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rabeprazole 5 mg, Teprenone 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.04 to 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rabeprazole 10 mg, Teprenone 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
0.01 to 0.23
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cumulative Incidence of Bleeding Ulcers
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 150 151 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events/100 participants/24 weeks
0
(0 to 0)
0
(0 to 0)
4.6
(2.24 to 9.48)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/156 (6.41%)   6/157 (3.82%)   10/158 (6.33%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Cardiac disorders       
Angina pectoris * 1  1/156 (0.64%)  0/157 (0.00%)  2/158 (1.27%) 
Gastrointestinal disorders       
Duodenal ulcer * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Duodenal ulcer haemorrhage * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Gastric ulcer haemorrhage * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Gastrointestinal haemorrhage * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Pancreatitis acute * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Vomiting * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
General disorders       
Chest discomfort * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Infections and infestations       
Pneumonia * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Pneumonia mycoplasmal * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Injury, poisoning and procedural complications       
Spinal compression fracture * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Subdural haematoma * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Hypoglycaemia * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Musculoskeletal and connective tissue disorders       
Polymyalgia rheumatica * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Rotator cuff syndrome * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Bile duct cancer * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Lung neoplasm malignant * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Gastric adenoma * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
Nervous system disorders       
Carotid artery stenosis * 1  0/156 (0.00%)  1/157 (0.64%)  0/158 (0.00%) 
Carpal tunnel syndrome * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Embolic stroke * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Renal and urinary disorders       
Renal artery stenosis * 1  0/156 (0.00%)  0/157 (0.00%)  1/158 (0.63%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration * 1  1/156 (0.64%)  0/157 (0.00%)  0/158 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Rabeprazole 5 mg Rabeprazole 10 mg Teprenone 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/156 (30.77%)   46/157 (29.30%)   41/158 (25.95%) 
Gastrointestinal disorders       
Constipation * 1  1/156 (0.64%)  5/157 (3.18%)  6/158 (3.80%) 
Diarrhoea * 1  4/156 (2.56%)  6/157 (3.82%)  2/158 (1.27%) 
Infections and infestations       
Nasopharyngitis * 1  25/156 (16.03%)  22/157 (14.01%)  25/158 (15.82%) 
Pharyngitis * 1  6/156 (3.85%)  1/157 (0.64%)  2/158 (1.27%) 
Upper respiratory tract infection * 1  5/156 (3.21%)  3/157 (1.91%)  2/158 (1.27%) 
Injury, poisoning and procedural complications       
Contusion * 1  4/156 (2.56%)  0/157 (0.00%)  3/158 (1.90%) 
Metabolism and nutrition disorders       
Diabetes mellitus * 1  4/156 (2.56%)  2/157 (1.27%)  1/158 (0.63%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis * 1  0/156 (0.00%)  1/157 (0.64%)  4/158 (2.53%) 
Skin and subcutaneous tissue disorders       
Eczema * 1  1/156 (0.64%)  6/157 (3.82%)  1/158 (0.63%) 
Vascular disorders       
Hypertension * 1  0/156 (0.00%)  5/157 (3.18%)  3/158 (1.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
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.
Other disclosure agreement that restricts the right of the PI 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: Nobuyuki Sugisaki
Organization: Eisai Co., Ltd.
Phone: +81-3-3817-3908 ext 3908
Layout table for additonal information
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