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Trial record 19 of 488 for:    ALS (Amyotrophic Lateral Sclerosis)

Efficacy and Safety Study of MCI-186 for Treatment of 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: NCT00330681
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
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 206
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description Edaravone 60 mg, intravenously infused over 60 min once daily. Edaravone matched placebo, intravenously infused over 60 min once daily.
Period Title: Overall Study
Started 102 104
Completed 93 90
Not Completed 9 14
Reason Not Completed
Adverse Event             3             6
Protocol Violation             0             1
Withdrawal by Subject             5             5
Tracheotomy due to worsening of ALS             1             2
Arm/Group Title MCI-186 Placebo of MCI-186 Total
Hide Arm/Group Description Edaravone 60 mg, intravenously infused over 60 min once daily. Edaravone matched placebo, intravenously infused over 60 min once daily. Total of all reporting groups
Overall Number of Baseline Participants 102 104 206
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 206 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 19 and 64 years
74
  72.5%
71
  68.3%
145
  70.4%
>=65 years
28
  27.5%
33
  31.7%
61
  29.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 206 participants
Female
38
  37.3%
35
  33.7%
73
  35.4%
Male
64
  62.7%
69
  66.3%
133
  64.6%
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 ALSFRS-R Score: 0=worst; 48=best
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

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

"5 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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 100 99
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.7  (0.85) -6.35  (0.84)
2.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
"1 patient with diseases other than ALS" was excluded from the FAS in the MCI-186 group.
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 101 104
Measure Type: Number
Unit of Measure: participants
death 2 2
disability of independent ambulation 28 23
loss of upper arm function 2 4
tracheotomy 0 2
use of respirator 1 3
use of tube feeding 5 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 with diseases other than ALS" and "1 patient who did not reach the end of cycle 3" were excluded from the FAS in the MCI-186 group.

"5 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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 100 99
Least Squares Mean (Standard Error)
Unit of Measure: percentage of FVC
-14.57  (2.41) -17.49  (2.39)
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. Worst=0, Best=102
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group.

"5 patients who did not reach the end of cycle 3" and "2 patients 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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 95 97
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.12  (2.05) -16.15  (2)
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, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

"1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group.

"5 patients who did not reach the end of cycle 3" and "4 patients 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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 95 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
19.6  (3.82) 19.13  (3.79)
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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 102 104
Measure Type: Number
Unit of Measure: percentage of participants
89.2 88.5
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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 102 104
Measure Type: Number
Unit of Measure: percentage of participants
13.7 19.2
8.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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
"1 patient with missing data" was excluded from the FAS in the Placebo of MCI-186 group.
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 102 103
Measure Type: Number
Unit of Measure: percentage of participants
White blood cell count 2 5.8
urinary glucose 6.9 2.9
9.Secondary Outcome
Title Percentage of Participants With Abnormal Changes in Sensory Examinations
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:
Edaravone 60 mg, intravenously infused over 60 min once daily.
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Number of Participants Analyzed 102 104
Measure Type: Number
Unit of Measure: percentage of participants
Numbness 1 1
Staggering 2 3.8
Vibratory sensation 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description Edaravone 60 mg, intravenously infused over 60 min once daily. Edaravone matched placebo, intravenously infused over 60 min once daily.
All-Cause Mortality
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   18/102 (17.65%)   24/104 (23.08%) 
Ear and labyrinth disorders     
Vertigo positional  0/102 (0.00%)  1/104 (0.96%) 
Gastrointestinal disorders     
Abdominal pain  1/102 (0.98%)  0/104 (0.00%) 
Ascites  0/102 (0.00%)  1/104 (0.96%) 
Dysphagia  8/102 (7.84%)  11/104 (10.58%) 
Intestinal ischaemia  1/102 (0.98%)  0/104 (0.00%) 
General disorders     
Abasia  1/102 (0.98%)  0/104 (0.00%) 
Gait disturbance  3/102 (2.94%)  2/104 (1.92%) 
Oedema peripheral  0/102 (0.00%)  1/104 (0.96%) 
Infections and infestations     
Cellulitis  0/102 (0.00%)  1/104 (0.96%) 
Gastroenteritis  1/102 (0.98%)  0/104 (0.00%) 
Pneumonia  1/102 (0.98%)  0/104 (0.00%) 
Injury, poisoning and procedural complications     
Subdural haematoma  0/102 (0.00%)  1/104 (0.96%) 
Metabolism and nutrition disorders     
Hypoproteinaemia  0/102 (0.00%)  1/104 (0.96%) 
Musculoskeletal and connective tissue disorders     
Mastication disorder  0/102 (0.00%)  1/104 (0.96%) 
Muscle spasms  0/102 (0.00%)  1/104 (0.96%) 
Muscular weakness  1/102 (0.98%)  1/104 (0.96%) 
Musculoskeletal disorder  3/102 (2.94%)  3/104 (2.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  0/102 (0.00%)  1/104 (0.96%) 
Nervous system disorders     
Dyslalia  1/102 (0.98%)  2/104 (1.92%) 
Psychiatric disorders     
Anxiety  0/102 (0.00%)  1/104 (0.96%) 
Depression  0/102 (0.00%)  1/104 (0.96%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  0/102 (0.00%)  1/104 (0.96%) 
Dyspnoea  2/102 (1.96%)  0/104 (0.00%) 
Haemoptysis  0/102 (0.00%)  1/104 (0.96%) 
Pneumonia aspiration  0/102 (0.00%)  1/104 (0.96%) 
Respiratory disorder  4/102 (3.92%)  0/104 (0.00%) 
Respiratory failure  1/102 (0.98%)  5/104 (4.81%) 
Sputum retention  1/102 (0.98%)  0/104 (0.00%) 
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 0%
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   88/102 (86.27%)   91/104 (87.50%) 
Blood and lymphatic system disorders     
Anaemia  0/102 (0.00%)  3/104 (2.88%) 
Cardiac disorders     
Palpitations  1/102 (0.98%)  0/104 (0.00%) 
Supraventricular extrasystoles  1/102 (0.98%)  0/104 (0.00%) 
Ear and labyrinth disorders     
Cerumen impaction  1/102 (0.98%)  0/104 (0.00%) 
Eustachian tube patulous  1/102 (0.98%)  0/104 (0.00%) 
Vertigo  0/102 (0.00%)  2/104 (1.92%) 
Vertigo positional  1/102 (0.98%)  1/104 (0.96%) 
Eye disorders     
Astigmatism  0/102 (0.00%)  1/104 (0.96%) 
Cataract  0/102 (0.00%)  2/104 (1.92%) 
Conjunctivitis  1/102 (0.98%)  0/104 (0.00%) 
Conjunctivitis allergic  0/102 (0.00%)  1/104 (0.96%) 
Dry eye  1/102 (0.98%)  0/104 (0.00%) 
Eye discharge  0/102 (0.00%)  1/104 (0.96%) 
Eye pain  1/102 (0.98%)  1/104 (0.96%) 
Eye pruritus  0/102 (0.00%)  1/104 (0.96%) 
Myodesopsia  1/102 (0.98%)  0/104 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1/102 (0.98%)  0/104 (0.00%) 
Abdominal pain  2/102 (1.96%)  0/104 (0.00%) 
Abdominal pain upper  2/102 (1.96%)  0/104 (0.00%) 
Anal prolapse  0/102 (0.00%)  1/104 (0.96%) 
Constipation  13/102 (12.75%)  17/104 (16.35%) 
Dental caries  1/102 (0.98%)  0/104 (0.00%) 
Diarrhoea  4/102 (3.92%)  5/104 (4.81%) 
Dysphagia  0/102 (0.00%)  1/104 (0.96%) 
Gastric ulcer  1/102 (0.98%)  0/104 (0.00%) 
Gastritis  2/102 (1.96%)  2/104 (1.92%) 
Gingival swelling  0/102 (0.00%)  1/104 (0.96%) 
Gingivitis  0/102 (0.00%)  1/104 (0.96%) 
Haemorrhoidal haemorrhage  0/102 (0.00%)  1/104 (0.96%) 
Haemorrhoids  0/102 (0.00%)  1/104 (0.96%) 
Inguinal hernia  1/102 (0.98%)  0/104 (0.00%) 
Nausea  2/102 (1.96%)  1/104 (0.96%) 
Periodontitis  1/102 (0.98%)  0/104 (0.00%) 
Sensitivity of teeth  1/102 (0.98%)  0/104 (0.00%) 
Stomach discomfort  0/102 (0.00%)  2/104 (1.92%) 
Stomatitis  1/102 (0.98%)  5/104 (4.81%) 
Tooth loss  1/102 (0.98%)  0/104 (0.00%) 
Toothache  1/102 (0.98%)  0/104 (0.00%) 
Vomiting  0/102 (0.00%)  1/104 (0.96%) 
General disorders     
Abasia  1/102 (0.98%)  0/104 (0.00%) 
Catheter site erythema  0/102 (0.00%)  1/104 (0.96%) 
Catheter site inflammation  0/102 (0.00%)  2/104 (1.92%) 
Catheter site pain  0/102 (0.00%)  1/104 (0.96%) 
Chest pain  2/102 (1.96%)  0/104 (0.00%) 
Feeling abnormal  1/102 (0.98%)  1/104 (0.96%) 
Gait disturbance  17/102 (16.67%)  14/104 (13.46%) 
Infusion site reaction  1/102 (0.98%)  0/104 (0.00%) 
Injection site phlebitis  0/102 (0.00%)  1/104 (0.96%) 
Local swelling  1/102 (0.98%)  0/104 (0.00%) 
Malaise  1/102 (0.98%)  0/104 (0.00%) 
Oedema  1/102 (0.98%)  0/104 (0.00%) 
Oedema peripheral  0/102 (0.00%)  3/104 (2.88%) 
Pyrexia  1/102 (0.98%)  1/104 (0.96%) 
Thirst  1/102 (0.98%)  0/104 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1/102 (0.98%)  5/104 (4.81%) 
Hepatic steatosis  2/102 (1.96%)  0/104 (0.00%) 
Liver disorder  2/102 (1.96%)  0/104 (0.00%) 
Immune system disorders     
Seasonal allergy  0/102 (0.00%)  1/104 (0.96%) 
Infections and infestations     
Bronchitis  2/102 (1.96%)  3/104 (2.88%) 
Cystitis  2/102 (1.96%)  2/104 (1.92%) 
Enterocolitis bacterial  0/102 (0.00%)  1/104 (0.96%) 
Folliculitis  0/102 (0.00%)  1/104 (0.96%) 
Gastroenteritis  0/102 (0.00%)  3/104 (2.88%) 
Herpes zoster  1/102 (0.98%)  1/104 (0.96%) 
Influenza  3/102 (2.94%)  2/104 (1.92%) 
Nail infection  1/102 (0.98%)  0/104 (0.00%) 
Nasopharyngitis  22/102 (21.57%)  22/104 (21.15%) 
Onychomycosis  1/102 (0.98%)  0/104 (0.00%) 
Oral herpes  1/102 (0.98%)  0/104 (0.00%) 
Otitis externa  0/102 (0.00%)  1/104 (0.96%) 
Otitis media  1/102 (0.98%)  1/104 (0.96%) 
Pharyngitis  3/102 (2.94%)  2/104 (1.92%) 
Pneumonia  0/102 (0.00%)  1/104 (0.96%) 
Purulence  1/102 (0.98%)  0/104 (0.00%) 
Rhinitis  0/102 (0.00%)  1/104 (0.96%) 
Tinea capitis  0/102 (0.00%)  1/104 (0.96%) 
Tinea cruris  0/102 (0.00%)  1/104 (0.96%) 
Tinea infection  1/102 (0.98%)  0/104 (0.00%) 
Tinea pedis  2/102 (1.96%)  1/104 (0.96%) 
Tonsillitis  0/102 (0.00%)  1/104 (0.96%) 
Tooth abscess  1/102 (0.98%)  0/104 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod sting  1/102 (0.98%)  2/104 (1.92%) 
Back injury  1/102 (0.98%)  1/104 (0.96%) 
Clavicle fracture  0/102 (0.00%)  1/104 (0.96%) 
Contusion  12/102 (11.76%)  5/104 (4.81%) 
Excoriation  3/102 (2.94%)  1/104 (0.96%) 
Foot fracture  0/102 (0.00%)  1/104 (0.96%) 
Joint dislocation  1/102 (0.98%)  1/104 (0.96%) 
Joint sprain  3/102 (2.94%)  0/104 (0.00%) 
Open wound  1/102 (0.98%)  1/104 (0.96%) 
Periorbital haematoma  0/102 (0.00%)  1/104 (0.96%) 
Rib fracture  0/102 (0.00%)  1/104 (0.96%) 
Skeletal injury  0/102 (0.00%)  1/104 (0.96%) 
Skin laceration  1/102 (0.98%)  2/104 (1.92%) 
Spinal compression fracture  0/102 (0.00%)  1/104 (0.96%) 
Subdural haematoma  0/102 (0.00%)  1/104 (0.96%) 
Thermal burn  0/102 (0.00%)  1/104 (0.96%) 
Tooth fracture  0/102 (0.00%)  2/104 (1.92%) 
Investigations     
Alanine aminotransferase increased  0/102 (0.00%)  1/104 (0.96%) 
Aspartate aminotransferase increased  0/102 (0.00%)  1/104 (0.96%) 
Blood alkaline phosphatase increased  0/102 (0.00%)  1/104 (0.96%) 
Blood creatine phosphokinase increased  1/102 (0.98%)  0/104 (0.00%) 
Blood pressure increased  0/102 (0.00%)  1/104 (0.96%) 
Blood urea increased  1/102 (0.98%)  0/104 (0.00%) 
Blood urine present  0/102 (0.00%)  1/104 (0.96%) 
Gamma-glutamyltransferase increased  1/102 (0.98%)  0/104 (0.00%) 
Glucose urine present  6/102 (5.88%)  3/104 (2.88%) 
Liver function test abnormal  1/102 (0.98%)  0/104 (0.00%) 
Protein urine present  0/102 (0.00%)  1/104 (0.96%) 
White blood cell count decreased  0/102 (0.00%)  2/104 (1.92%) 
Metabolism and nutrition disorders     
Anorexia  1/102 (0.98%)  0/104 (0.00%) 
Dehydration  1/102 (0.98%)  0/104 (0.00%) 
Hyperkalaemia  0/102 (0.00%)  1/104 (0.96%) 
Hyperlipidaemia  0/102 (0.00%)  1/104 (0.96%) 
Type 2 diabetes mellitus  1/102 (0.98%)  0/104 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  2/102 (1.96%)  1/104 (0.96%) 
Back pain  3/102 (2.94%)  5/104 (4.81%) 
Bursitis  0/102 (0.00%)  1/104 (0.96%) 
Dupuytren's contracture  1/102 (0.98%)  0/104 (0.00%) 
Limb discomfort  1/102 (0.98%)  0/104 (0.00%) 
Muscular weakness  6/102 (5.88%)  8/104 (7.69%) 
Musculoskeletal pain  2/102 (1.96%)  3/104 (2.88%) 
Neck pain  2/102 (1.96%)  0/104 (0.00%) 
Osteoarthritis  1/102 (0.98%)  1/104 (0.96%) 
Osteoporosis  1/102 (0.98%)  0/104 (0.00%) 
Periarthritis  0/102 (0.00%)  1/104 (0.96%) 
Spinal column stenosis  0/102 (0.00%)  2/104 (1.92%) 
Spinal osteoarthritis  1/102 (0.98%)  0/104 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1/102 (0.98%)  0/104 (0.00%) 
Nervous system disorders     
Dizziness  1/102 (0.98%)  2/104 (1.92%) 
Dizziness postural  0/102 (0.00%)  1/104 (0.96%) 
Headache  8/102 (7.84%)  3/104 (2.88%) 
Intercostal neuralgia  1/102 (0.98%)  0/104 (0.00%) 
Migraine  1/102 (0.98%)  0/104 (0.00%) 
Pallanaesthesia  0/102 (0.00%)  1/104 (0.96%) 
Post herpetic neuralgia  1/102 (0.98%)  0/104 (0.00%) 
Sensory disturbance  0/102 (0.00%)  1/104 (0.96%) 
Tension headache  2/102 (1.96%)  0/104 (0.00%) 
Psychiatric disorders     
Anxiety  0/102 (0.00%)  1/104 (0.96%) 
Insomnia  9/102 (8.82%)  10/104 (9.62%) 
Renal and urinary disorders     
Calculus urinary  1/102 (0.98%)  0/104 (0.00%) 
Dysuria  0/102 (0.00%)  1/104 (0.96%) 
Nocturia  0/102 (0.00%)  1/104 (0.96%) 
Pollakiuria  1/102 (0.98%)  0/104 (0.00%) 
Proteinuria  0/102 (0.00%)  1/104 (0.96%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1/102 (0.98%)  0/104 (0.00%) 
Epididymitis  0/102 (0.00%)  1/104 (0.96%) 
Gynaecomastia  1/102 (0.98%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  0/102 (0.00%)  1/104 (0.96%) 
Cough  1/102 (0.98%)  2/104 (1.92%) 
Dyspnoea  0/102 (0.00%)  1/104 (0.96%) 
Hypoxia  1/102 (0.98%)  0/104 (0.00%) 
Oropharyngeal pain  1/102 (0.98%)  1/104 (0.96%) 
Pneumonia aspiration  0/102 (0.00%)  1/104 (0.96%) 
Sputum retention  0/102 (0.00%)  1/104 (0.96%) 
Upper respiratory tract inflammation  1/102 (0.98%)  2/104 (1.92%) 
Skin and subcutaneous tissue disorders     
Acrodermatitis  0/102 (0.00%)  1/104 (0.96%) 
Blister  1/102 (0.98%)  0/104 (0.00%) 
Dermal cyst  1/102 (0.98%)  0/104 (0.00%) 
Dermatitis  1/102 (0.98%)  0/104 (0.00%) 
Dermatitis contact  3/102 (2.94%)  2/104 (1.92%) 
Drug eruption  0/102 (0.00%)  1/104 (0.96%) 
Eczema  7/102 (6.86%)  2/104 (1.92%) 
Eczema asteatotic  0/102 (0.00%)  3/104 (2.88%) 
Erythema  3/102 (2.94%)  2/104 (1.92%) 
Excessive granulation tissue  1/102 (0.98%)  0/104 (0.00%) 
Haemorrhage subcutaneous  0/102 (0.00%)  2/104 (1.92%) 
Hidradenitis  1/102 (0.98%)  0/104 (0.00%) 
Pruritus  1/102 (0.98%)  3/104 (2.88%) 
Purpura  1/102 (0.98%)  1/104 (0.96%) 
Rash  4/102 (3.92%)  2/104 (1.92%) 
Rash pruritic  0/102 (0.00%)  1/104 (0.96%) 
Skin exfoliation  1/102 (0.98%)  0/104 (0.00%) 
Toxic skin eruption  1/102 (0.98%)  0/104 (0.00%) 
Urticaria  1/102 (0.98%)  1/104 (0.96%) 
Xeroderma  1/102 (0.98%)  0/104 (0.00%) 
Vascular disorders     
Essential hypertension  1/102 (0.98%)  0/104 (0.00%) 
Haematoma  1/102 (0.98%)  0/104 (0.00%) 
Hypertension  2/102 (1.96%)  2/104 (1.92%) 
Phlebitis  0/102 (0.00%)  1/104 (0.96%) 
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: NCT00330681     History of Changes
Other Study ID Numbers: MCI186-16
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: October 28, 2016
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017