Trial Outcomes & Findings for Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes (NCT NCT00497198)
NCT ID: NCT00497198
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
0 weeks
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
MCI-196
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
91
|
|
Overall Study
COMPLETED
|
87
|
86
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
MCI-196
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
MCI-196
n=92 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=91 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=37 Participants
|
55 Participants
n=56 Participants
|
115 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=37 Participants
|
36 Participants
n=56 Participants
|
68 Participants
n=82 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=37 Participants
|
34 Participants
n=56 Participants
|
67 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=37 Participants
|
57 Participants
n=56 Participants
|
116 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: 0 weeksPopulation: Per protocol set
Outcome measures
| Measure |
MCI-196
n=86 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=86 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Fasting Plasma Glucose at Baseline
|
170.2 mg/dL
Standard Deviation 21.1
|
168.2 mg/dL
Standard Deviation 20.5
|
PRIMARY outcome
Timeframe: 12 weeks (baseline to week 12)Population: Per protocol set; Last observation carried forward
Outcome measures
| Measure |
MCI-196
n=86 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=86 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Change From Baseline in Blood Glucose at Week 12
|
-21.3 mg/dL
Standard Error 2.2
|
0.8 mg/dL
Standard Error 2.2
|
PRIMARY outcome
Timeframe: 0 weeksPopulation: Per protocol set
Outcome measures
| Measure |
MCI-196
n=86 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=86 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) at Baseline
|
7.97 percentage
Standard Deviation 0.72
|
7.94 percentage
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: 12 weeks (baseline to week 12)Population: Per protocol set; Last observation carried forward
Outcome measures
| Measure |
MCI-196
n=86 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=86 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
|
-0.70 percentage
Standard Error 0.06
|
0.18 percentage
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 12 weeks (baseline to week 12)Outcome measures
| Measure |
MCI-196
n=86 Participants
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=86 Participants
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
|
-28.9 mg/dL
Standard Error 2.0
|
-0.2 mg/dL
Standard Error 2.0
|
Adverse Events
MCI-196
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-196
n=92 participants at risk
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=91 participants at risk
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Gastrointestinal disorders
Colon polyp
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
Other adverse events
| Measure |
MCI-196
n=92 participants at risk
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
|
Placebo
n=91 participants at risk
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Eye disorders
Cataract
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
2.2%
2/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Eye disorders
Corneal erosion
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Eye disorders
Diabetic retinopathy
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Eye disorders
Episcleritis
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Eye disorders
Eye pain
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
2.2%
2/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Constipation
|
13.0%
12/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
4.4%
4/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
4.4%
4/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Faeces hard
|
3.3%
3/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Gastritis atrophic
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
2.2%
2/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
General disorders
Pyrexia
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Bronchitis
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Cystitis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Folliculitis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Influenza
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
2.2%
2/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Nasopharyngitis
|
19.6%
18/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
13.2%
12/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Otitis media
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Paronychia
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Pharyngitis
|
2.2%
2/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
2/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
2/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasma
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Dizziness
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
2.2%
2/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Migraine
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Sciatica
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Tension headache
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
3.3%
3/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.3%
4/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
3.3%
3/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.4%
5/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
0.00%
0/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
2/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Skin and subcutaneous tissue disorders
Schamberg's disease
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/92 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
1.1%
1/91 • 1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER