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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00424463
Collaborator
(none)
181
Enrollment
1
Location
2
Arms
28
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: MCI-186
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
Other Names:
  • Edaravone
  • Radicut

    		•
    Placebo Comparator: 2

    Drug: Placebo of MCI-186
    Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks [baseline (seventh cycle) and at 24 week (twelfth cycle)]

      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.

    Secondary Outcome Measures

    1. Number of Participants With Death or a Specified State of Disease Progression [24 weeks (from seventh cycle to twelfth cycle)]

      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.

    2. Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks [baseline (seventh cycle) and at 24 week (twelfth cycle)]

      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.

    3. Percentage of Participants With Adverse Events [36 weeks (from seventh cycle to fifteenth cycle)]

    4. Percentage of Participants With Adverse Drug Reactions [36 weeks (from seventh cycle to fifteenth cycle)]

    5. Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group [36 weeks (from seventh cycle to fifteenth cycle)]

    6. Percentage of Participants With Abnormal Changes in Sensory Examinations [36 weeks (from seventh cycle to fifteenth cycle)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.
    Exclusion Criteria:

    • Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.

    • Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.

    • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.

    • Patients who are participating in other clinical trials except the study NCT00330681.

    • In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Hospital Organization Miyagi National Hospital Watari-gun Miyagi-ken Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Chair: Koji Abe, professor, Graduate School of Medicine and Dentistry, Okayama University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT00424463
    Other Study ID Numbers:
    • MCI186-17
    First Posted:
    Jan 19, 2007
    Last Update Posted:
    Aug 23, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    Amyotrophic lateral sclerosis (ALS)
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis
    Edaravone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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

    Baseline Characteristics

    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186 Total
    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 Participants 45 48 88 181
    Age (Count of Participants)
    <=18 years
    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 (Count of 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%

    Outcome Measures

    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
    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)

    Outcome Measure Data

    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
    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
    Measure Participants 40 43 74
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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
    Measure Participants 44 48 88
    death
    1
    2.2%
    1
    2.1%
    1
    1.1%
    disability of independent ambulation
    8
    17.8%
    11
    22.9%
    20
    22.7%
    loss of upper arm function
    3
    6.7%
    5
    10.4%
    7
    8%
    tracheotomy
    0
    0%
    0
    0%
    2
    2.3%
    use of respirator
    0
    0%
    1
    2.1%
    2
    2.3%
    use of tube feeding
    1
    2.2%
    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
    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)

    Outcome Measure Data

    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
    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
    Measure Participants 40 42 69
    Mean (Standard Deviation) [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
    Description
    Time Frame 36 weeks (from seventh cycle to fifteenth cycle)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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
    Measure Participants 45 48 88
    Number [percentage of participant]
    97.8
    91.7
    92
    5. Secondary Outcome
    Title Percentage of Participants With Adverse Drug Reactions
    Description
    Time Frame 36 weeks (from seventh cycle to fifteenth cycle)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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
    Measure Participants 45 48 88
    Number [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
    Description
    Time Frame 36 weeks (from seventh cycle to fifteenth cycle)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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
    Measure Participants 45 48 88
    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
    Description
    Time Frame 36 weeks (from seventh cycle to fifteenth cycle)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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
    Measure Participants 45 48 88
    Numbness
    0
    0
    0
    Staggering
    0
    2.1
    2.3
    Vibratory sensation
    0
    0
    0

    Adverse Events

    Time Frame from baseline (seventh cycle) to 36 weeks (fifteenth cycle)
    Adverse Event Reporting Description
    Arm/Group Title MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/45 (28.9%) 25/48 (52.1%) 39/88 (44.3%)
    Cardiac disorders
    Cardiac arrest 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Eye disorders
    Retinal vein occlusion 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Gastrointestinal disorders
    Colonic polyp 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Dysphagia 6/45 (13.3%) 9/48 (18.8%) 22/88 (25%)
    Enterocolitis 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Gastric ulcer 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Stomach discomfort 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    General disorders
    Abasia 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Gait disturbance 0/45 (0%) 4/48 (8.3%) 5/88 (5.7%)
    Infections and infestations
    Bronchitis 1/45 (2.2%) 1/48 (2.1%) 0/88 (0%)
    Bronchopneumonia 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Catheter site infection 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Diverticulitis 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Herpes zoster 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Pneumonia 0/45 (0%) 1/48 (2.1%) 2/88 (2.3%)
    Injury, poisoning and procedural complications
    Head injury 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Humerus fracture 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Joint sprain 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Skin laceration 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Musculoskeletal and connective tissue disorders
    Muscular weakness 0/45 (0%) 1/48 (2.1%) 3/88 (3.4%)
    Musculoskeletal disorder 4/45 (8.9%) 6/48 (12.5%) 10/88 (11.4%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Prostate cancer 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Nervous system disorders
    Dysarthria 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Dyslalia 1/45 (2.2%) 0/48 (0%) 6/88 (6.8%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 2/45 (4.4%) 3/48 (6.3%) 2/88 (2.3%)
    Hypercapnia 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Pneumonia aspiration 1/45 (2.2%) 1/48 (2.1%) 1/88 (1.1%)
    Respiratory arrest 0/45 (0%) 0/48 (0%) 1/88 (1.1%)
    Respiratory disorder 1/45 (2.2%) 2/48 (4.2%) 2/88 (2.3%)
    Respiratory failure 2/45 (4.4%) 6/48 (12.5%) 6/88 (6.8%)
    Sputum retention 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Other (Not Including Serious) Adverse Events
    MCI-186 - Placebo of MCI-186 MCI-186 - MCI-186 Placebo of MCI-186 - MCI-186
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 43/45 (95.6%) 43/48 (89.6%) 74/88 (84.1%)
    Blood and lymphatic system disorders
    Anaemia 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Ear and labyrinth disorders
    Ear discomfort 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Tinnitus 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Vertigo 2/45 (4.4%) 0/48 (0%) 2/88 (2.3%)
    Eye disorders
    Cataract 1/45 (2.2%) 2/48 (4.2%) 0/88 (0%)
    Conjunctivitis 0/45 (0%) 0/48 (0%) 3/88 (3.4%)
    Conjunctivitis allergic 2/45 (4.4%) 1/48 (2.1%) 0/88 (0%)
    Dry eye 1/45 (2.2%) 1/48 (2.1%) 1/88 (1.1%)
    Eye discharge 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Ocular hyperaemia 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Retinal detachment 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Abdominal pain lower 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Abdominal pain upper 2/45 (4.4%) 1/48 (2.1%) 1/88 (1.1%)
    Cheilitis 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Constipation 8/45 (17.8%) 10/48 (20.8%) 20/88 (22.7%)
    Dental caries 0/45 (0%) 1/48 (2.1%) 4/88 (4.5%)
    Diarrhoea 1/45 (2.2%) 3/48 (6.3%) 6/88 (6.8%)
    Dry mouth 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Dysphagia 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Gastric ulcer 2/45 (4.4%) 0/48 (0%) 0/88 (0%)
    Gastritis 1/45 (2.2%) 2/48 (4.2%) 2/88 (2.3%)
    Gingivitis 0/45 (0%) 1/48 (2.1%) 2/88 (2.3%)
    Haemorrhoids 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Lip dry 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Lip swelling 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Loose tooth 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Malocclusion 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Nausea 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Periodontal disease 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Periodontitis 0/45 (0%) 0/48 (0%) 3/88 (3.4%)
    Reflux oesophagitis 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Stomach discomfort 2/45 (4.4%) 1/48 (2.1%) 1/88 (1.1%)
    Stomatitis 0/45 (0%) 1/48 (2.1%) 4/88 (4.5%)
    Tongue ulceration 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Toothache 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    General disorders
    Catheter site erythema 0/45 (0%) 2/48 (4.2%) 0/88 (0%)
    Chest discomfort 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Chest pain 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Feeling abnormal 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Gait disturbance 9/45 (20%) 10/48 (20.8%) 27/88 (30.7%)
    Impaired healing 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Pyrexia 1/45 (2.2%) 3/48 (6.3%) 2/88 (2.3%)
    Thirst 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Hepatobiliary disorders
    Hepatic function abnormal 0/45 (0%) 2/48 (4.2%) 0/88 (0%)
    Liver disorder 0/45 (0%) 1/48 (2.1%) 3/88 (3.4%)
    Immune system disorders
    Seasonal allergy 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Infections and infestations
    Bronchitis 2/45 (4.4%) 0/48 (0%) 3/88 (3.4%)
    Catheter site infection 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Cystitis 1/45 (2.2%) 1/48 (2.1%) 0/88 (0%)
    Enteritis infectious 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Enterocolitis viral 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Folliculitis 1/45 (2.2%) 1/48 (2.1%) 0/88 (0%)
    Gastroenteritis 2/45 (4.4%) 0/48 (0%) 1/88 (1.1%)
    Infected epidermal cyst 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Nasopharyngitis 12/45 (26.7%) 10/48 (20.8%) 28/88 (31.8%)
    Oral herpes 0/45 (0%) 1/48 (2.1%) 2/88 (2.3%)
    Otitis media 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Periodontal infection 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Pharyngitis 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Pneumonia 1/45 (2.2%) 1/48 (2.1%) 0/88 (0%)
    Rhinitis 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Sinobronchitis 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Sweat gland infection 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Tinea cruris 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Tinea infection 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Tinea pedis 3/45 (6.7%) 3/48 (6.3%) 4/88 (4.5%)
    Urinary tract infection 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Injury, poisoning and procedural complications
    Avulsion fracture 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Back injury 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Contusion 7/45 (15.6%) 3/48 (6.3%) 8/88 (9.1%)
    Excoriation 1/45 (2.2%) 1/48 (2.1%) 2/88 (2.3%)
    Facial bones fracture 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Fractured coccyx 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Joint dislocation 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Joint sprain 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Open wound 1/45 (2.2%) 1/48 (2.1%) 2/88 (2.3%)
    Post gastric surgery syndrome 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Skin laceration 1/45 (2.2%) 0/48 (0%) 3/88 (3.4%)
    Tooth fracture 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Foot fracture 1/45 (2.2%) 1/48 (2.1%) 1/88 (1.1%)
    Investigations
    Blood creatine phosphokinase increased 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Blood potassium increased 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Blood pressure decreased 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Blood urine present 0/45 (0%) 0/48 (0%) 3/88 (3.4%)
    Gamma-glutamyltransferase increased 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Glucose urine present 0/45 (0%) 1/48 (2.1%) 2/88 (2.3%)
    White blood cell count increased 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Metabolism and nutrition disorders
    Glucose tolerance impaired 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Hyperlipidaemia 1/45 (2.2%) 0/48 (0%) 1/88 (1.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/45 (6.7%) 0/48 (0%) 2/88 (2.3%)
    Back pain 2/45 (4.4%) 0/48 (0%) 3/88 (3.4%)
    Monarthritis 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Muscular weakness 3/45 (6.7%) 0/48 (0%) 2/88 (2.3%)
    Musculoskeletal disorder 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Musculoskeletal pain 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Neck pain 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Osteoarthritis 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Pain in extremity 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Pain in jaw 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Periarthritis 1/45 (2.2%) 1/48 (2.1%) 0/88 (0%)
    Temporomandibular joint syndrome 1/45 (2.2%) 1/48 (2.1%) 1/88 (1.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pyogenic granuloma 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Nervous system disorders
    Dizziness 1/45 (2.2%) 2/48 (4.2%) 0/88 (0%)
    Dysgeusia 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Headache 2/45 (4.4%) 1/48 (2.1%) 4/88 (4.5%)
    Hyposmia 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Sciatica 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Somnolence 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Tension headache 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Psychiatric disorders
    Anxiety 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Anxiety disorder 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Depression 2/45 (4.4%) 0/48 (0%) 3/88 (3.4%)
    Insomnia 3/45 (6.7%) 5/48 (10.4%) 7/88 (8%)
    Renal and urinary disorders
    Dysuria 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Hypertonic bladder 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Nocturia 0/45 (0%) 2/48 (4.2%) 0/88 (0%)
    Pollakiuria 1/45 (2.2%) 1/48 (2.1%) 2/88 (2.3%)
    Urinary retention 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Respiratory, thoracic and mediastinal disorders
    Aspiration 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Cough 0/45 (0%) 0/48 (0%) 5/88 (5.7%)
    Dyspnoea 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Epistaxis 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Nasal congestion 1/45 (2.2%) 0/48 (0%) 2/88 (2.3%)
    Nasal septum deviation 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Pneumonia aspiration 0/45 (0%) 0/48 (0%) 2/88 (2.3%)
    Respiratory disorder 0/45 (0%) 1/48 (2.1%) 1/88 (1.1%)
    Rhinitis allergic 1/45 (2.2%) 1/48 (2.1%) 2/88 (2.3%)
    Upper respiratory tract inflammation 1/45 (2.2%) 3/48 (6.3%) 4/88 (4.5%)
    Skin and subcutaneous tissue disorders
    Blister 1/45 (2.2%) 0/48 (0%) 0/88 (0%)
    Decubitus ulcer 1/45 (2.2%) 1/48 (2.1%) 1/88 (1.1%)
    Dermatitis 2/45 (4.4%) 1/48 (2.1%) 1/88 (1.1%)
    Dermatitis contact 0/45 (0%) 2/48 (4.2%) 2/88 (2.3%)
    Drug eruption 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Eczema 3/45 (6.7%) 3/48 (6.3%) 3/88 (3.4%)
    Erythema 3/45 (6.7%) 2/48 (4.2%) 2/88 (2.3%)
    Excessive granulation tissue 0/45 (0%) 1/48 (2.1%) 4/88 (4.5%)
    Pruritus 1/45 (2.2%) 1/48 (2.1%) 8/88 (9.1%)
    Purpura 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Rash 1/45 (2.2%) 1/48 (2.1%) 4/88 (4.5%)
    Rash pruritic 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Seborrhoeic dermatitis 0/45 (0%) 1/48 (2.1%) 2/88 (2.3%)
    Skin exfoliation 0/45 (0%) 1/48 (2.1%) 0/88 (0%)
    Vascular disorders
    Hypertension 0/45 (0%) 2/48 (4.2%) 0/88 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Clinical Trials, Information Desk
    Organization Mitsubishi Tanabe Pharma Corporation
    Phone
    Email cti-inq-ml@ml.mt-pharma.co.jp
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT00424463
    Other Study ID Numbers:
    • MCI186-17
    First Posted:
    Jan 19, 2007
    Last Update Posted:
    Aug 23, 2018
    Last Verified:
    Jul 1, 2018