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Trial record 8 of 488 for:    ALS (Amyotrophic Lateral Sclerosis)

Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

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: NCT00424463
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : June 4, 2018
Last Update Posted : August 23, 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 of MCI-186
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Period Title: Overall Study
Started 45 48 88
Completed 38 34 72
Not Completed 7 14 16
Reason Not Completed
Adverse Event             2             3             2
Physician Decision             0             2             2
Withdrawal by Subject             4             2             5
Tracheotomy due to worsening of ALS             1             7             6
Patient’s convenience             0             0             1
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186 Total
Hide Arm/Group Description Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Total of all reporting groups
Overall Number of Baseline Participants 45 48 88 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 88 participants 181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  84.4%
29
  60.4%
62
  70.5%
129
  71.3%
>=65 years
7
  15.6%
19
  39.6%
26
  29.5%
52
  28.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 88 participants 181 participants
Female
12
  26.7%
22
  45.8%
31
  35.2%
65
  35.9%
Male
33
  73.3%
26
  54.2%
57
  64.8%
116
  64.1%
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 To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.
Time Frame baseline (seventh cycle) and at 24 week (twelfth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient with diseases other than ALS" and "4 patients with missing data" were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.

"5 patients with missing data" were excluded from the FAS in the MCI-186 - MCI-186 group.

"14 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group.

Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 40 43 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.5  (4.6) -4.2  (4) -5.4  (4.5)
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 arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event.
Time Frame 24 weeks (from seventh cycle to twelfth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
"1 patient with diseases other than ALS" was excluded from the FAS in the MCI-186 - Placebo of MCI-186 group.
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 44 48 88
Measure Type: Count of Participants
Unit of Measure: Participants
death
1
   2.3%
1
   2.1%
1
   1.1%
disability of independent ambulation
8
  18.2%
11
  22.9%
20
  22.7%
loss of upper arm function
3
   6.8%
5
  10.4%
7
   8.0%
tracheotomy
0
   0.0%
0
   0.0%
2
   2.3%
use of respirator
0
   0.0%
1
   2.1%
2
   2.3%
use of tube feeding
1
   2.3%
1
   2.1%
8
   9.1%
3.Secondary Outcome
Title Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.
Time Frame baseline (seventh cycle) and at 24 week (twelfth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient with diseases other than ALS" and "4 patients with missing data" were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.

"6 patients with missing data" were excluded from the FAS in the MCI-186 - MCI-186 group.

"19 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group.

Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 40 42 69
Mean (Standard Deviation)
Unit of Measure: percentage of FVC
-10.6  (13.16) -12.91  (14.97) -10.54  (13.21)
4.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 36 weeks (from seventh cycle to fifteenth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 45 48 88
Measure Type: Number
Unit of Measure: percentage of participant
97.8 91.7 92
5.Secondary Outcome
Title Percentage of Participants With Adverse Drug Reactions
Hide Description [Not Specified]
Time Frame 36 weeks (from seventh cycle to fifteenth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 45 48 88
Measure Type: Number
Unit of Measure: percentage of participant
4.4 10.4 10.2
6.Secondary Outcome
Title Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
Hide Description [Not Specified]
Time Frame 36 weeks (from seventh cycle to fifteenth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 45 48 88
Measure Type: Number
Unit of Measure: percentage of participant
White blood cell count 11.1 4.2 10.2
Alanine aminotransferase 0 6.3 4.5
Urinary glucose 0 6.3 3.4
7.Secondary Outcome
Title Percentage of Participants With Abnormal Changes in Sensory Examinations
Hide Description [Not Specified]
Time Frame 36 weeks (from seventh cycle to fifteenth cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description:
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
Overall Number of Participants Analyzed 45 48 88
Measure Type: Number
Unit of Measure: percentage of participant
Numbness 0 0 0
Staggering 0 2.1 2.3
Vibratory sensation 0 0 0
Time Frame from baseline (seventh cycle) to 36 weeks (fifteenth cycle)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Hide Arm/Group Description Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
All-Cause Mortality
MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/45 (28.89%)   25/48 (52.08%)   39/88 (44.32%) 
Cardiac disorders       
Cardiac arrest  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Eye disorders       
Retinal vein occlusion  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Gastrointestinal disorders       
Colonic polyp  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Dysphagia  6/45 (13.33%)  9/48 (18.75%)  22/88 (25.00%) 
Enterocolitis  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Gastric ulcer  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Stomach discomfort  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
General disorders       
Abasia  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Gait disturbance  0/45 (0.00%)  4/48 (8.33%)  5/88 (5.68%) 
Infections and infestations       
Bronchitis  1/45 (2.22%)  1/48 (2.08%)  0/88 (0.00%) 
Bronchopneumonia  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Catheter site infection  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Diverticulitis  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Herpes zoster  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Pneumonia  0/45 (0.00%)  1/48 (2.08%)  2/88 (2.27%) 
Injury, poisoning and procedural complications       
Head injury  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Humerus fracture  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Joint sprain  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Skin laceration  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Musculoskeletal and connective tissue disorders       
Muscular weakness  0/45 (0.00%)  1/48 (2.08%)  3/88 (3.41%) 
Musculoskeletal disorder  4/45 (8.89%)  6/48 (12.50%)  10/88 (11.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Prostate cancer  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Nervous system disorders       
Dysarthria  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Dyslalia  1/45 (2.22%)  0/48 (0.00%)  6/88 (6.82%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  2/45 (4.44%)  3/48 (6.25%)  2/88 (2.27%) 
Hypercapnia  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Pneumonia aspiration  1/45 (2.22%)  1/48 (2.08%)  1/88 (1.14%) 
Respiratory arrest  0/45 (0.00%)  0/48 (0.00%)  1/88 (1.14%) 
Respiratory disorder  1/45 (2.22%)  2/48 (4.17%)  2/88 (2.27%) 
Respiratory failure  2/45 (4.44%)  6/48 (12.50%)  6/88 (6.82%) 
Sputum retention  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/45 (95.56%)   43/48 (89.58%)   74/88 (84.09%) 
Blood and lymphatic system disorders       
Anaemia  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Ear and labyrinth disorders       
Ear discomfort  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Tinnitus  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Vertigo  2/45 (4.44%)  0/48 (0.00%)  2/88 (2.27%) 
Eye disorders       
Cataract  1/45 (2.22%)  2/48 (4.17%)  0/88 (0.00%) 
Conjunctivitis  0/45 (0.00%)  0/48 (0.00%)  3/88 (3.41%) 
Conjunctivitis allergic  2/45 (4.44%)  1/48 (2.08%)  0/88 (0.00%) 
Dry eye  1/45 (2.22%)  1/48 (2.08%)  1/88 (1.14%) 
Eye discharge  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Ocular hyperaemia  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Retinal detachment  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Abdominal pain lower  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Abdominal pain upper  2/45 (4.44%)  1/48 (2.08%)  1/88 (1.14%) 
Cheilitis  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Constipation  8/45 (17.78%)  10/48 (20.83%)  20/88 (22.73%) 
Dental caries  0/45 (0.00%)  1/48 (2.08%)  4/88 (4.55%) 
Diarrhoea  1/45 (2.22%)  3/48 (6.25%)  6/88 (6.82%) 
Dry mouth  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Dysphagia  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Gastric ulcer  2/45 (4.44%)  0/48 (0.00%)  0/88 (0.00%) 
Gastritis  1/45 (2.22%)  2/48 (4.17%)  2/88 (2.27%) 
Gingivitis  0/45 (0.00%)  1/48 (2.08%)  2/88 (2.27%) 
Haemorrhoids  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Lip dry  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Lip swelling  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Loose tooth  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Malocclusion  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Nausea  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Periodontal disease  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Periodontitis  0/45 (0.00%)  0/48 (0.00%)  3/88 (3.41%) 
Reflux oesophagitis  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Stomach discomfort  2/45 (4.44%)  1/48 (2.08%)  1/88 (1.14%) 
Stomatitis  0/45 (0.00%)  1/48 (2.08%)  4/88 (4.55%) 
Tongue ulceration  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Toothache  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
General disorders       
Catheter site erythema  0/45 (0.00%)  2/48 (4.17%)  0/88 (0.00%) 
Chest discomfort  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Chest pain  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Feeling abnormal  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Gait disturbance  9/45 (20.00%)  10/48 (20.83%)  27/88 (30.68%) 
Impaired healing  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Pyrexia  1/45 (2.22%)  3/48 (6.25%)  2/88 (2.27%) 
Thirst  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Hepatobiliary disorders       
Hepatic function abnormal  0/45 (0.00%)  2/48 (4.17%)  0/88 (0.00%) 
Liver disorder  0/45 (0.00%)  1/48 (2.08%)  3/88 (3.41%) 
Immune system disorders       
Seasonal allergy  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Infections and infestations       
Bronchitis  2/45 (4.44%)  0/48 (0.00%)  3/88 (3.41%) 
Catheter site infection  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Cystitis  1/45 (2.22%)  1/48 (2.08%)  0/88 (0.00%) 
Enteritis infectious  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Enterocolitis viral  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Folliculitis  1/45 (2.22%)  1/48 (2.08%)  0/88 (0.00%) 
Gastroenteritis  2/45 (4.44%)  0/48 (0.00%)  1/88 (1.14%) 
Infected epidermal cyst  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Nasopharyngitis  12/45 (26.67%)  10/48 (20.83%)  28/88 (31.82%) 
Oral herpes  0/45 (0.00%)  1/48 (2.08%)  2/88 (2.27%) 
Otitis media  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Periodontal infection  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Pharyngitis  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Pneumonia  1/45 (2.22%)  1/48 (2.08%)  0/88 (0.00%) 
Rhinitis  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Sinobronchitis  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Sweat gland infection  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Tinea cruris  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Tinea infection  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Tinea pedis  3/45 (6.67%)  3/48 (6.25%)  4/88 (4.55%) 
Urinary tract infection  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Injury, poisoning and procedural complications       
Avulsion fracture  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Back injury  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Contusion  7/45 (15.56%)  3/48 (6.25%)  8/88 (9.09%) 
Excoriation  1/45 (2.22%)  1/48 (2.08%)  2/88 (2.27%) 
Facial bones fracture  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Fractured coccyx  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Joint dislocation  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Joint sprain  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Open wound  1/45 (2.22%)  1/48 (2.08%)  2/88 (2.27%) 
Post gastric surgery syndrome  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Skin laceration  1/45 (2.22%)  0/48 (0.00%)  3/88 (3.41%) 
Tooth fracture  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Foot fracture  1/45 (2.22%)  1/48 (2.08%)  1/88 (1.14%) 
Investigations       
Blood creatine phosphokinase increased  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Blood potassium increased  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Blood pressure decreased  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Blood urine present  0/45 (0.00%)  0/48 (0.00%)  3/88 (3.41%) 
Gamma-glutamyltransferase increased  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Glucose urine present  0/45 (0.00%)  1/48 (2.08%)  2/88 (2.27%) 
White blood cell count increased  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Metabolism and nutrition disorders       
Glucose tolerance impaired  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Hyperlipidaemia  1/45 (2.22%)  0/48 (0.00%)  1/88 (1.14%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  3/45 (6.67%)  0/48 (0.00%)  2/88 (2.27%) 
Back pain  2/45 (4.44%)  0/48 (0.00%)  3/88 (3.41%) 
Monarthritis  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Muscular weakness  3/45 (6.67%)  0/48 (0.00%)  2/88 (2.27%) 
Musculoskeletal disorder  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Musculoskeletal pain  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Neck pain  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Osteoarthritis  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Pain in extremity  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Pain in jaw  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Periarthritis  1/45 (2.22%)  1/48 (2.08%)  0/88 (0.00%) 
Temporomandibular joint syndrome  1/45 (2.22%)  1/48 (2.08%)  1/88 (1.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pyogenic granuloma  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Nervous system disorders       
Dizziness  1/45 (2.22%)  2/48 (4.17%)  0/88 (0.00%) 
Dysgeusia  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Headache  2/45 (4.44%)  1/48 (2.08%)  4/88 (4.55%) 
Hyposmia  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Sciatica  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Somnolence  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Tension headache  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Psychiatric disorders       
Anxiety  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Anxiety disorder  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Depression  2/45 (4.44%)  0/48 (0.00%)  3/88 (3.41%) 
Insomnia  3/45 (6.67%)  5/48 (10.42%)  7/88 (7.95%) 
Renal and urinary disorders       
Dysuria  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Hypertonic bladder  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Nocturia  0/45 (0.00%)  2/48 (4.17%)  0/88 (0.00%) 
Pollakiuria  1/45 (2.22%)  1/48 (2.08%)  2/88 (2.27%) 
Urinary retention  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Aspiration  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Cough  0/45 (0.00%)  0/48 (0.00%)  5/88 (5.68%) 
Dyspnoea  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Epistaxis  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Nasal congestion  1/45 (2.22%)  0/48 (0.00%)  2/88 (2.27%) 
Nasal septum deviation  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Pneumonia aspiration  0/45 (0.00%)  0/48 (0.00%)  2/88 (2.27%) 
Respiratory disorder  0/45 (0.00%)  1/48 (2.08%)  1/88 (1.14%) 
Rhinitis allergic  1/45 (2.22%)  1/48 (2.08%)  2/88 (2.27%) 
Upper respiratory tract inflammation  1/45 (2.22%)  3/48 (6.25%)  4/88 (4.55%) 
Skin and subcutaneous tissue disorders       
Blister  1/45 (2.22%)  0/48 (0.00%)  0/88 (0.00%) 
Decubitus ulcer  1/45 (2.22%)  1/48 (2.08%)  1/88 (1.14%) 
Dermatitis  2/45 (4.44%)  1/48 (2.08%)  1/88 (1.14%) 
Dermatitis contact  0/45 (0.00%)  2/48 (4.17%)  2/88 (2.27%) 
Drug eruption  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Eczema  3/45 (6.67%)  3/48 (6.25%)  3/88 (3.41%) 
Erythema  3/45 (6.67%)  2/48 (4.17%)  2/88 (2.27%) 
Excessive granulation tissue  0/45 (0.00%)  1/48 (2.08%)  4/88 (4.55%) 
Pruritus  1/45 (2.22%)  1/48 (2.08%)  8/88 (9.09%) 
Purpura  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Rash  1/45 (2.22%)  1/48 (2.08%)  4/88 (4.55%) 
Rash pruritic  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Seborrhoeic dermatitis  0/45 (0.00%)  1/48 (2.08%)  2/88 (2.27%) 
Skin exfoliation  0/45 (0.00%)  1/48 (2.08%)  0/88 (0.00%) 
Vascular disorders       
Hypertension  0/45 (0.00%)  2/48 (4.17%)  0/88 (0.00%) 
1
Term from vocabulary, MedDRA 11.1
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: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00424463     History of Changes
Other Study ID Numbers: MCI186-17
First Submitted: January 17, 2007
First Posted: January 19, 2007
Results First Submitted: September 6, 2017
Results First Posted: June 4, 2018
Last Update Posted: August 23, 2018