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Trial record 96 of 677 for:    amyotrophic lateral sclerosis

Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

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: NCT01492686
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis (ALS)
Interventions Drug: MCI-186
Drug: Placebo
Drug: MCI-186 in open label phase
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Period Title: Double-blind Phase
Started 69 68
Completed 67 60
Not Completed 2 8
Reason Not Completed
Adverse Event             0             2
Physician Decision             0             1
Withdrawal by Subject             0             2
Due to a discontinuation criterion             2             3
Period Title: Open-label Phase
Started 65 58
Completed 53 40
Not Completed 12 18
Reason Not Completed
Adverse Event             1             2
Physician Decision             1             0
Withdrawal by Subject             6             7
Due to a discontinuation criterion             4             9
Arm/Group Title MCI-186 Placebo of MCI-186 Total
Hide Arm/Group Description Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion. Total of all reporting groups
Overall Number of Baseline Participants 69 68 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 137 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  66.7%
46
  67.6%
92
  67.2%
>=65 years
23
  33.3%
22
  32.4%
45
  32.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 137 participants
Female
31
  44.9%
27
  39.7%
58
  42.3%
Male
38
  55.1%
41
  60.3%
79
  57.7%
1.Primary Outcome
Title Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description 0=worst; 48=best
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group.

"2 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 68 66
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.01  (0.64) -7.5  (0.66)
2.Secondary Outcome
Title Number of Participants With Death or a Specified State of Disease Progression
Hide Description Any of “death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech” was defined as an event.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 69 68
Measure Type: Number
Unit of Measure: Count of Participants
Death 0 0
Disability of independent ambulation 0 2
Loss of upper limbs function 0 0
Tracheotomy 1 0
Use of respirator 0 0
Use of tube feeding 0 1
Loss of useful speech 1 3
3.Secondary Outcome
Title Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description [Not Specified]
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient who did not reach the end of cycle 3" and "1 patient with missing data" were excluded from the FAS in the MCI-186 group.

"2 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 67 66
Least Squares Mean (Standard Error)
Unit of Measure: percentage of FVC
-15.61  (2.41) -20.4  (2.48)
4.Secondary Outcome
Title Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group.

"2 patients who did not reach the end of cycle 3" and "3 patient with missing data" were excluded from the FAS in the Placebo of MCI-186 group.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 68 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-15.91  (1.97) -20.8  (2.06)
5.Secondary Outcome
Title Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group.

"2 patients who did not reach the end of cycle 3" and "2 patient with missing data" were excluded from the FAS in the Placebo of MCI-186 group.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 68 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
17.25  (3.39) 26.04  (3.53)
6.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 69 68
Measure Type: Number
Unit of Measure: percentage of Participants
84.1 83.8
7.Secondary Outcome
Title Percentage of Participants With Adverse Drug Reactions
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 69 68
Measure Type: Number
Unit of Measure: percentage of Participants
2.9 7.4
8.Secondary Outcome
Title Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 69 68
Measure Type: Number
Unit of Measure: percentage of Participants
Blood bilirubin increased 0 1.5
Blood creatine phosphokinase increased 0 1.5
Liver function test abnormal 1.4 1.5
White blood cell count decreased 1.4 0
9.Secondary Outcome
Title Percentage of Participants With Abnormal Values in Sensory Examinations
Hide Description [Not Specified]
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

A note:

Four patients of Placebo of MCI-186 group did not have data at 24 week. Therefore, concerning numbness (at 24 week) and staggering (at 24 week), the number of participants analysed are 64 in the both groups.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Overall Number of Participants Analyzed 69 68
Measure Type: Number
Unit of Measure: percentage of Participants
Numbness (at baseline) 2.9 7.4
Numbness (at 24 week) 7.2 9.4
Staggering (at baseline) 1.4 8.8
Staggering (at 24 week) 2.9 3.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Double-blind MCI-186 Double-blind Placebo of MCI-186 Open-label MCI-186 (Double-blind MCI-186, Then Open-label) Open-label MCI-186 (Double-blind Placebo, Then Open-label)
Hide Arm/Group Description MCI-186 in Double-blind. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. Placebo of MCI-186 in Double-blind. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion. MCI-186 in Open-label (Double-blind MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. MCI-186 in Open-label (Double-blind Placebo of MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
All-Cause Mortality
Double-blind MCI-186 Double-blind Placebo of MCI-186 Open-label MCI-186 (Double-blind MCI-186, Then Open-label) Open-label MCI-186 (Double-blind Placebo, Then Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind MCI-186 Double-blind Placebo of MCI-186 Open-label MCI-186 (Double-blind MCI-186, Then Open-label) Open-label MCI-186 (Double-blind Placebo, Then Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/69 (15.94%)   16/68 (23.53%)   17/65 (26.15%)   23/58 (39.66%) 
Cardiac disorders         
Stress cardiomyopathy  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Gastrointestinal disorders         
Dysphagia  8/69 (11.59%)  8/68 (11.76%)  6/65 (9.23%)  13/58 (22.41%) 
Lower gastrointestinal haemorrhage  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  1/58 (1.72%) 
General disorders         
Gait disturbance  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  0/58 (0.00%) 
Hepatobiliary disorders         
Drug-induced liver injury  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Cholecystitis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Infections and infestations         
Bacterial infection  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Bronchitis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal disorder  0/69 (0.00%)  1/68 (1.47%)  3/65 (4.62%)  2/58 (3.45%) 
Nervous system disorders         
Speech disorder  1/69 (1.45%)  2/68 (2.94%)  2/65 (3.08%)  1/58 (1.72%) 
Psychiatric disorders         
Depression  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  1/58 (1.72%) 
Adjustment disorder  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  0/69 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  1/58 (1.72%) 
Pneumonia aspiration  0/69 (0.00%)  2/68 (2.94%)  2/65 (3.08%)  3/58 (5.17%) 
Respiratory disorder  2/69 (2.90%)  2/68 (2.94%)  4/65 (6.15%)  4/58 (6.90%) 
Respiratory failure  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  3/58 (5.17%) 
Vascular disorders         
Shock  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Double-blind MCI-186 Double-blind Placebo of MCI-186 Open-label MCI-186 (Double-blind MCI-186, Then Open-label) Open-label MCI-186 (Double-blind Placebo, Then Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   57/69 (82.61%)   51/68 (75.00%)   53/65 (81.54%)   48/58 (82.76%) 
Blood and lymphatic system disorders         
Anaemia  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Cardiac disorders         
Arrhythmia  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Tachycardia  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Stress cardiomyopathy  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Ear and labyrinth disorders         
Deafness neurosensory  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Vertigo  0/69 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/58 (0.00%) 
Vertigo positional  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Sudden hearing loss  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Eye disorders         
Blepharitis  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Eye discharge  1/69 (1.45%)  1/68 (1.47%)  2/65 (3.08%)  0/58 (0.00%) 
Retinal tear  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Conjunctivitis allergic  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Diplopia  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Dry eye  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Eczema eyelids  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  2/69 (2.90%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Cheilitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Constipation  8/69 (11.59%)  8/68 (11.76%)  7/65 (10.77%)  8/58 (13.79%) 
Diarrhoea  2/69 (2.90%)  4/68 (5.88%)  2/65 (3.08%)  2/58 (3.45%) 
Dysphagia  0/69 (0.00%)  2/68 (2.94%)  6/65 (9.23%)  13/58 (22.41%) 
Gastritis  1/69 (1.45%)  0/68 (0.00%)  3/65 (4.62%)  0/58 (0.00%) 
Haemorrhoids  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Malocclusion  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Nausea  2/69 (2.90%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Periodontal disease  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Stomatitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  2/58 (3.45%) 
Change of bowel habit  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Dental caries  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Dyspepsia  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Gastric ulcer  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Anal inflammation  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Lower gastrointestinal haemorrhage  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Epigastric discomfort  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
General disorders         
Catheter site dermatitis  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Feeling hot  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Infusion site erythema  3/69 (4.35%)  2/68 (2.94%)  2/65 (3.08%)  1/58 (1.72%) 
Infusion site pain  3/69 (4.35%)  2/68 (2.94%)  0/65 (0.00%)  1/58 (1.72%) 
Infusion site phlebitis  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Infusion site swelling  0/69 (0.00%)  2/68 (2.94%)  1/65 (1.54%)  0/58 (0.00%) 
Injection site rash  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Injection site reaction  0/69 (0.00%)  2/68 (2.94%)  0/65 (0.00%)  2/58 (3.45%) 
Pain  0/69 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  2/58 (3.45%) 
Pyrexia  0/69 (0.00%)  3/68 (4.41%)  1/65 (1.54%)  0/58 (0.00%) 
Swelling  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Gait disturbance  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  0/58 (0.00%) 
Malaise  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Catheter site haemorrhage  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  1/58 (1.72%) 
Catheter site erythema  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Catheter site inflammation  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Infusion site pruritus  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Puncture site swelling  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Hepatobiliary disorders         
Hepatic function abnormal  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Cholecystitis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Immune system disorders         
Seasonal allergy  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  1/58 (1.72%) 
Infections and infestations         
Cellulitis  2/69 (2.90%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Chronic sinusitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Conjunctivitis  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Dermatitis infected  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Device related infection  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Gastroenteritis  1/69 (1.45%)  1/68 (1.47%)  2/65 (3.08%)  0/58 (0.00%) 
Gingival abscess  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Herpes zoster  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Infected dermal cyst  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Nasopharyngitis  3/69 (4.35%)  5/68 (7.35%)  6/65 (9.23%)  4/58 (6.90%) 
Oral herpes  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Otitis externa  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  1/58 (1.72%) 
Periodontitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Pharyngitis  2/69 (2.90%)  2/68 (2.94%)  1/65 (1.54%)  1/58 (1.72%) 
Postoperative wound infection  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Tinea infection  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Tinea pedis  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Upper respiratory tract infection  2/69 (2.90%)  1/68 (1.47%)  1/65 (1.54%)  0/58 (0.00%) 
Bronchitis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Gingivitis  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Herpes simplex  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Influenza  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Oral candidiasis  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Tinea cruris  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Catheter site infection  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  0/58 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod bite  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Chillblains  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  2/58 (3.45%) 
Contusion  13/69 (18.84%)  8/68 (11.76%)  6/65 (9.23%)  6/58 (10.34%) 
Excoriation  2/69 (2.90%)  2/68 (2.94%)  3/65 (4.62%)  0/58 (0.00%) 
Foot fracture  0/69 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/58 (0.00%) 
Injury  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Laceration  1/69 (1.45%)  2/68 (2.94%)  1/65 (1.54%)  1/58 (1.72%) 
Ligament sprain  2/69 (2.90%)  2/68 (2.94%)  1/65 (1.54%)  2/58 (3.45%) 
Lip injury  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Procedural pain  2/69 (2.90%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Radius fracture  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Spinal compression fracture  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Wound  0/69 (0.00%)  1/68 (1.47%)  4/65 (6.15%)  2/58 (3.45%) 
Bite  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Head injury  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Rib fracture  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Wound compliation  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Tooth fracture  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Investigations         
Blood bilirubin increased  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Blood creatine phosphokinase increased  0/69 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/58 (0.00%) 
Liver function test abnormal  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
White blood cell count decreased  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Blood pressure increased  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Gamma-glutamyltransferase increased  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Blood urine present  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
White blood cell count increased  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Protein urine present  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Metabolism and nutrition disorders         
Gout  0/69 (0.00%)  2/68 (2.94%)  0/65 (0.00%)  0/58 (0.00%) 
Hyperlipidaemia  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Hypokalaemia  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1/69 (1.45%)  2/68 (2.94%)  4/65 (6.15%)  1/58 (1.72%) 
Arthritis  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Back pain  4/69 (5.80%)  1/68 (1.47%)  2/65 (3.08%)  0/58 (0.00%) 
Bursitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Chondrocalcinosis pyrophosphate  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Muscular weakness  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Musculoskeletal pain  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  2/58 (3.45%) 
Myalgia  4/69 (5.80%)  1/68 (1.47%)  0/65 (0.00%)  1/58 (1.72%) 
Myofascial pain syndrome  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Neck pain  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Pain in extremity  2/69 (2.90%)  1/68 (1.47%)  1/65 (1.54%)  1/58 (1.72%) 
Periarthritis  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Temporomandibular joint syndrome  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Musculoskeletal disorder  0/69 (0.00%)  0/68 (0.00%)  3/65 (4.62%)  2/58 (3.45%) 
Tendon pain  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Nervous system disorders         
Carpal tunnel syndrome  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Decreased vibratory sense  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Dizziness  2/69 (2.90%)  2/68 (2.94%)  0/65 (0.00%)  0/58 (0.00%) 
Dysgeusia  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Headache  4/69 (5.80%)  5/68 (7.35%)  1/65 (1.54%)  3/58 (5.17%) 
Hypoaesthesia  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Sciatica  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Speech disorder  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  1/58 (1.72%) 
Tremor  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Psychiatric disorders         
Insomnia  5/69 (7.25%)  4/68 (5.88%)  2/65 (3.08%)  2/58 (3.45%) 
Anxiety  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Depression  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Neurosis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Adjustment disorder  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Renal and urinary disorders         
Dysuria  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Pollakiuria  0/69 (0.00%)  2/68 (2.94%)  2/65 (3.08%)  1/58 (1.72%) 
Haematuria  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Incontinence  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/58 (1.72%) 
Nocturia  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Nasal congestion  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Oropharyngeal discomfort  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Oropharyngeal pain  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Respiratory disorder  1/69 (1.45%)  0/68 (0.00%)  4/65 (6.15%)  4/58 (6.90%) 
Rhinitis allergic  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Upper respiratory tract inflammation  5/69 (7.25%)  2/68 (2.94%)  4/65 (6.15%)  1/58 (1.72%) 
Asthma  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Dyspnoea  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  1/58 (1.72%) 
Epistaxis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Pneumonia aspiration  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  3/58 (5.17%) 
Respiratory failure  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  3/58 (5.17%) 
Skin and subcutaneous tissue disorders         
Asteatosis  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Blister  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Decubitus ulcer  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Dermatitis contact  8/69 (11.59%)  3/68 (4.41%)  3/65 (4.62%)  1/58 (1.72%) 
Dry skin  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Eczema  5/69 (7.25%)  2/68 (2.94%)  5/65 (7.69%)  2/58 (3.45%) 
Erythema  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Haemorrhage subcutaneous  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Henoch-Schonlein purpura  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Hyperkeratosis  1/69 (1.45%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Miliaria  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Pruritus  0/69 (0.00%)  3/68 (4.41%)  5/65 (7.69%)  1/58 (1.72%) 
Rash  1/69 (1.45%)  2/68 (2.94%)  1/65 (1.54%)  0/58 (0.00%) 
Skin exfoliation  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Skin lesion  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Skin ulcer  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Urticaria  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  1/58 (1.72%) 
Acne  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Dermatitis  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Eczema asteatotic  0/69 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  0/58 (0.00%) 
Seborrhoeic dermatitis  0/69 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  2/58 (3.45%) 
Toxic skin eruption  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
Excessive granulation tissue  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  2/58 (3.45%) 
Vascular disorders         
Hypertension  1/69 (1.45%)  0/68 (0.00%)  1/65 (1.54%)  1/58 (1.72%) 
Hypotension  0/69 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/58 (0.00%) 
Phlebitis  0/69 (0.00%)  2/68 (2.94%)  0/65 (0.00%)  0/58 (0.00%) 
Vasculitis  1/69 (1.45%)  0/68 (0.00%)  0/65 (0.00%)  0/58 (0.00%) 
Shock  0/69 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/58 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
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: NCT01492686     History of Changes
Other Study ID Numbers: MCI186-19
First Submitted: December 11, 2011
First Posted: December 15, 2011
Results First Submitted: September 6, 2017
Results First Posted: December 31, 2018
Last Update Posted: December 31, 2018