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Trial record 35 of 252 for:    ASPIRIN AND low-dose aspirin

Long-term 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: NCT01398410
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : November 16, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Intervention Drug: Rabeprazole
Enrollment 405
Recruitment Details  
Pre-assignment Details From a total of 420 participants who completed the E3810-J081-308 (NCT01397448) study, 405 entered the E3810-J081-309 (NCT01398410) study.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg
Hide Arm/Group Description Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
Period Title: Overall Study
Started 201 [1] 204
Completed 143 148
Not Completed 58 56
Reason Not Completed
Adverse Event             12             16
Participants Choice             8             11
Inadequate Therapeutic Effect             2             0
Not Specified             36             29
[1]
Treated participants (all participants who received at least one dose of rabeprazole).
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg Total
Hide Arm/Group Description Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily Total of all reporting groups
Overall Number of Baseline Participants 201 204 405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 204 participants 405 participants
69.4  (8.5) 70.1  (9.3) 69.8  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 204 participants 405 participants
Female
48
  23.9%
52
  25.5%
100
  24.7%
Male
153
  76.1%
152
  74.5%
305
  75.3%
1.Primary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.
Time Frame For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg
Hide Arm/Group Description:
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
Overall Number of Participants Analyzed 201 204
Measure Type: Number
Unit of Measure: Percentage of participants
77.1 83.8
2.Secondary Outcome
Title Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Hide Description Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.
Time Frame Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.
Arm/Group Title Rabeprazole 5 mg Rabeprazole 10 mg
Hide Arm/Group Description:
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
Overall Number of Participants Analyzed 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (N=150, 151)
0
(0 to 0)
0
(0 to 0)
Week 12 (N=150, 151)
1.3
(0.34 to 5.23)
0
(0 to 0)
Week 24 (N=139, 142)
2.8
(1.04 to 7.17)
1.4
(0.35 to 5.51)
Week 52 (N=107, 121)
3.7
(1.53 to 8.64)
2.2
(0.72 to 6.75)
Week 76 (N=93, 96)
3.7
(1.53 to 8.64)
2.2
(0.72 to 6.75)
Time Frame For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug or up to 76 weeks (including data from the Double-Blind Phase)
Adverse Event Reporting Description In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug (rabeprazole) up to 30 days after the final dose of study drug) were assessed.
 
Arm/Group Title Rabeprazole 5 mg Rabeprazole10 mg
Hide Arm/Group Description Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
All-Cause Mortality
Rabeprazole 5 mg Rabeprazole10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rabeprazole 5 mg Rabeprazole10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   33/201 (16.42%)   30/204 (14.71%) 
Cardiac disorders     
Acute myocardial infarction  1  1/201 (0.50%)  0/204 (0.00%) 
Angina pectoris  1  3/201 (1.49%)  1/204 (0.49%) 
Cardiac failure chronic  1  1/201 (0.50%)  0/204 (0.00%) 
Mitral valve incompetence  1  1/201 (0.50%)  0/204 (0.00%) 
Tricuspid valve incompetence  1  1/201 (0.50%)  0/204 (0.00%) 
Ear and labyrinth disorders     
Vertigo positional  1  1/201 (0.50%)  0/204 (0.00%) 
Eye disorders     
Cataract  1  2/201 (1.00%)  1/204 (0.49%) 
Gastrointestinal disorders     
Colonic polyp  1  0/201 (0.00%)  1/204 (0.49%) 
Diverticulum intestinal haemorrhagic  1  1/201 (0.50%)  0/204 (0.00%) 
Gastric ulcer haemorrhage  1  0/201 (0.00%)  1/204 (0.49%) 
Gastrointestinal haemorrhage  1  0/201 (0.00%)  1/204 (0.49%) 
Ileus  1  0/201 (0.00%)  1/204 (0.49%) 
Inguinal hernia  1  0/201 (0.00%)  1/204 (0.49%) 
Pancreatitis acute  1  1/201 (0.50%)  1/204 (0.49%) 
Vomiting  1  1/201 (0.50%)  0/204 (0.00%) 
General disorders     
Chest discomfort  1  0/201 (0.00%)  1/204 (0.49%) 
Device dislocation  1  1/201 (0.50%)  0/204 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/201 (0.00%)  1/204 (0.49%) 
Infections and infestations     
Bronchitis  1  1/201 (0.50%)  0/204 (0.00%) 
Pharyngitis  1  1/201 (0.50%)  0/204 (0.00%) 
Upper respiratory tract infection  1  1/201 (0.50%)  0/204 (0.00%) 
Urinary tract infection  1  0/201 (0.00%)  1/204 (0.49%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/201 (0.50%)  1/204 (0.49%) 
Spinal compression fracture  1  1/201 (0.50%)  1/204 (0.49%) 
Subdural haematoma  1  0/201 (0.00%)  1/204 (0.49%) 
Contusion  1  1/201 (0.50%)  0/204 (0.00%) 
Meniscus lesion  1  0/201 (0.00%)  1/204 (0.49%) 
Coronary artery restenosis  1  2/201 (1.00%)  0/204 (0.00%) 
Lower limb fracture  1  0/201 (0.00%)  1/204 (0.49%) 
Spinal column injury  1  0/201 (0.00%)  1/204 (0.49%) 
Investigations     
Blood pressure increased  1  1/201 (0.50%)  1/204 (0.49%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  1/201 (0.50%)  0/204 (0.00%) 
Hypoglycaemia  1  1/201 (0.50%)  0/204 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/201 (0.00%)  1/204 (0.49%) 
Polymyalgia rheumatica  1  0/201 (0.00%)  1/204 (0.49%) 
Rotator cuff syndrome  1  1/201 (0.50%)  0/204 (0.00%) 
Tenosynovitis  1  0/201 (0.00%)  1/204 (0.49%) 
Intervertebral disc protrusion  1  1/201 (0.50%)  0/204 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/201 (0.50%)  0/204 (0.00%) 
Bile duct cancer  1  0/201 (0.00%)  1/204 (0.49%) 
Breast cancer  1  1/201 (0.50%)  0/204 (0.00%) 
Gastric cancer  1  1/201 (0.50%)  4/204 (1.96%) 
Oesophageal carcinoma  1  0/201 (0.00%)  1/204 (0.49%) 
Lung neoplasm malignant  1  1/201 (0.50%)  0/204 (0.00%) 
Large intestine carcinoma  1  0/201 (0.00%)  1/204 (0.49%) 
Gastric adenoma  1  1/201 (0.50%)  1/204 (0.49%) 
Prostate cancer  1  1/201 (0.50%)  1/204 (0.49%) 
Nervous system disorders     
Brain stem infarction  1  1/201 (0.50%)  0/204 (0.00%) 
Carotid artery stenosis  1  0/201 (0.00%)  1/204 (0.49%) 
Cerebral infarction  1  1/201 (0.50%)  1/204 (0.49%) 
Transient ischaemic attack  1  1/201 (0.50%)  0/204 (0.00%) 
Lacunar infarction  1  1/201 (0.50%)  0/204 (0.00%) 
Psychiatric disorders     
Completed suicide  1  1/201 (0.50%)  0/204 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration  1  1/201 (0.50%)  0/204 (0.00%) 
Surgical and medical procedures     
Haemorrhoid operation  1  1/201 (0.50%)  0/204 (0.00%) 
Vascular disorders     
Artery dissection  1  1/201 (0.50%)  0/204 (0.00%) 
Peripheral arterial occlusive disease  1  1/201 (0.50%)  1/204 (0.49%) 
Indicates events were collected by 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 5%
Rabeprazole 5 mg Rabeprazole10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   89/201 (44.28%)   99/204 (48.53%) 
Gastrointestinal disorders     
Diarrhoea  1  11/201 (5.47%)  16/204 (7.84%) 
Constipation  1  9/201 (4.48%)  16/204 (7.84%) 
Infections and infestations     
Nasopharyngitis  1  64/201 (31.84%)  57/204 (27.94%) 
Injury, poisoning and procedural complications     
Contusion  1  13/201 (6.47%)  7/204 (3.43%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  14/201 (6.97%)  13/204 (6.37%) 
Skin and subcutaneous tissue disorders     
Eczema  1  6/201 (2.99%)  12/204 (5.88%) 
Indicates events were collected by 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.
 
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: NCT01398410     History of Changes
Other Study ID Numbers: E3810-J081-309
First Submitted: July 18, 2011
First Posted: July 20, 2011
Results First Submitted: October 16, 2015
Results First Posted: November 16, 2015
Last Update Posted: December 21, 2015