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Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00200356
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebral Infarction
Interventions Drug: Edaravone
Drug: Sodium Ozagrel
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Period Title: Overall Study
Started 199 202
Safety Analysis Set 194 198
Completed 191 195
Not Completed 8 7
Reason Not Completed
Lack of Efficacy             3             3
Protocol Violation             4             4
Nontreatment             1             0
Arm/Group Title Edaravone Ozagrel Total
Hide Arm/Group Description Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. Total of all reporting groups
Overall Number of Baseline Participants 191 195 386
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 191 participants 195 participants 386 participants
birth-19 years 0 0 0
20-64 years 64 58 122
65- years 127 137 264
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 195 participants 386 participants
Female
70
  36.6%
77
  39.5%
147
  38.1%
Male
121
  63.4%
118
  60.5%
239
  61.9%
1.Primary Outcome
Title the Rate of Patients With a Modified Rankin Scale Score of 0-1
Hide Description The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 191 195
Measure Type: Number
Unit of Measure: participants
Score(0-1) 109 98
0 46 39
1 63 59
2 37 40
3 22 29
4 19 24
5 2 3
Death 2 1
2.Secondary Outcome
Title Barthel Index Score
Hide Description

The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.

The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 191 195
Measure Type: Number
Unit of Measure: participants
148 133
3.Secondary Outcome
Title Baseline NIH Stroke Scale Score
Hide Description The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).
Time Frame Before treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 191 195
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.7  (2.3) 3.8  (2.7)
4.Secondary Outcome
Title NIH Stroke Scale Score at 14 Days
Hide Description The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 190 193
Measure Type: Number
Unit of Measure: participants
98 108
5.Secondary Outcome
Title NIH Stroke Scale Score at 1 Month
Hide Description The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 190 195
Measure Type: Number
Unit of Measure: participants
117 119
6.Secondary Outcome
Title NIH Stroke Scale Score at 3 Months
Hide Description The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 191 195
Measure Type: Number
Unit of Measure: participants
135 140
7.Secondary Outcome
Title Japan Stroke Scale (Motor Function) Score at 14 Days
Hide Description The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 190 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.521  (6.651) 4.686  (6.872)
8.Secondary Outcome
Title Japan Stroke Scale (Motor Function) Score at 1 Month
Hide Description The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 190 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.632  (6.086) 3.680  (5.885)
9.Secondary Outcome
Title Japan Stroke Scale (Motor Function) Score at 3 Months
Hide Description The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 189 194
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.507  (5.232) 2.927  (5.361)
10.Secondary Outcome
Title Modified Rankin Scale Score
Hide Description The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description:
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Overall Number of Participants Analyzed 186 193
Measure Type: Number
Unit of Measure: participants
112 108
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Edaravone Ozagrel
Hide Arm/Group Description Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
All-Cause Mortality
Edaravone Ozagrel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Edaravone Ozagrel
Affected / at Risk (%) Affected / at Risk (%)
Total   27/194 (13.92%)   28/198 (14.14%) 
Cardiac disorders     
Angina pectoris  1/194 (0.52%)  0/198 (0.00%) 
Arrhythmia  1/194 (0.52%)  0/198 (0.00%) 
Cardiac failure  0/194 (0.00%)  1/198 (0.51%) 
Ear and labyrinth disorders     
Vertigo  1/194 (0.52%)  0/198 (0.00%) 
Gastrointestinal disorders     
Constipation  0/194 (0.00%)  1/198 (0.51%) 
Duodenal ulcer  1/194 (0.52%)  0/198 (0.00%) 
Duodenal ulcer haemorrhage  1/194 (0.52%)  0/198 (0.00%) 
Ileus  2/194 (1.03%)  0/198 (0.00%) 
Inguinal hernia  1/194 (0.52%)  0/198 (0.00%) 
Vomiting  0/194 (0.00%)  1/198 (0.51%) 
Hepatobiliary disorders     
Liver disorder  0/194 (0.00%)  1/198 (0.51%) 
Immune system disorders     
Anti-neutrophil cytoplasmic antibody positive vasculitis  1/194 (0.52%)  0/198 (0.00%) 
Infections and infestations     
Erysipelas  0/194 (0.00%)  1/198 (0.51%) 
Pharyngitis  0/194 (0.00%)  1/198 (0.51%) 
Pneumonia  2/194 (1.03%)  1/198 (0.51%) 
Urinary tract infection  1/194 (0.52%)  1/198 (0.51%) 
Injury, poisoning and procedural complications     
Anastomotic ulcer haemorrhage  1/194 (0.52%)  0/198 (0.00%) 
Brain herniation  0/194 (0.00%)  1/198 (0.51%) 
Femoral neck fracture  1/194 (0.52%)  0/198 (0.00%) 
Femur fracture  1/194 (0.52%)  0/198 (0.00%) 
Pelvic fracture  1/194 (0.52%)  0/198 (0.00%) 
Spinal compression fracture  0/194 (0.00%)  1/198 (0.51%) 
Upper limb fracture  0/194 (0.00%)  1/198 (0.51%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  0/194 (0.00%)  1/198 (0.51%) 
Lymphoma  1/194 (0.52%)  0/198 (0.00%) 
Nervous system disorders     
Carpal tunnel syndrome  0/194 (0.00%)  1/198 (0.51%) 
Cerebral haemorrhage  1/194 (0.52%)  0/198 (0.00%) 
Cerebral infarction  5/194 (2.58%)  11/198 (5.56%) 
Haemorrhagic cerebral infarction  0/194 (0.00%)  1/198 (0.51%) 
Hemiplegia  0/194 (0.00%)  2/198 (1.01%) 
Loss of consciousness  0/194 (0.00%)  1/198 (0.51%) 
Sciatica  0/194 (0.00%)  1/198 (0.51%) 
Thrombotic stroke  1/194 (0.52%)  0/198 (0.00%) 
Transient ischemic attack  2/194 (1.03%)  0/198 (0.00%) 
Psychiatric disorders     
Depression  1/194 (0.52%)  0/198 (0.00%) 
Psychotic disorder due to a general medical condition  1/194 (0.52%)  0/198 (0.00%) 
Renal and urinary disorders     
Renal failure acute  0/194 (0.00%)  1/198 (0.51%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1/194 (0.52%)  0/198 (0.00%) 
Pneumonia aspiration  0/194 (0.00%)  1/198 (0.51%) 
Pulmonary embolism  0/194 (0.00%)  1/198 (0.51%) 
Vascular disorders     
Arteriosclerosis  0/194 (0.00%)  1/198 (0.51%) 
Shock haemorrhagic  0/194 (0.00%)  1/198 (0.51%) 
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Edaravone Ozagrel
Affected / at Risk (%) Affected / at Risk (%)
Total   102/194 (52.58%)   107/198 (54.04%) 
Gastrointestinal disorders     
Constipation  59/194 (30.41%)  64/198 (32.32%) 
Diarrhea  10/194 (5.15%)  6/198 (3.03%) 
Infections and infestations     
Nasopharyngitis  19/194 (9.79%)  13/198 (6.57%) 
Urinary tract infection  9/194 (4.64%)  11/198 (5.56%) 
Musculoskeletal and connective tissue disorders     
Back pain  11/194 (5.67%)  17/198 (8.59%) 
Nervous system disorders     
Headache  11/194 (5.67%)  12/198 (6.06%) 
Psychiatric disorders     
Insomnia  24/194 (12.37%)  33/198 (16.67%) 
Skin and subcutaneous tissue disorders     
Pruritus  9/194 (4.64%)  10/198 (5.05%) 
1
Term from vocabulary, MedDRA 9.1
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00200356    
Other Study ID Numbers: MCI186-13
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: September 13, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 15, 2013