Trial Outcomes & Findings for A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema (NCT NCT00479336)
NCT ID: NCT00479336
Last Updated: 2014-03-14
Results Overview
Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Baseline, Day 7 or at the discontied of treatment
Results posted on
2014-03-14
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
15 mg, 1 tablet a day
|
OPC-41061 30 mg
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
25
|
26
|
|
Overall Study
COMPLETED
|
23
|
20
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
1
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
15 mg, 1 tablet a day
|
OPC-41061 30 mg
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
2
|
|
Overall Study
Resolution of all hepatic edema findings
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
n=25 Participants
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
n=25 Participants
15 mg, 1 tablet a day
|
OPC-41061 30 mg
n=25 Participants
30 mg, 1 tablet a day
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
63.9 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
101 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7 or at the discontied of treatmentPopulation: Full Analysis Set; LOCF
Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
n=25 Participants
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
n=25 Participants
15 mg, 1 tablet a day
|
OPC-41061 30 mg
n=25 Participants
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Body Weight (Amount of Change)
|
-0.68 Kg
Standard Deviation 2.50
|
-2.31 Kg
Standard Deviation 2.35
|
-1.88 Kg
Standard Deviation 2.45
|
-1.67 Kg
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Baseline, Day 7 or at the discontied of treatmentPopulation: Full Analysis Set; LOCF
Change in abdominal circumference from baseline (LOCF)
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
n=25 Participants
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
n=25 Participants
15 mg, 1 tablet a day
|
OPC-41061 30 mg
n=25 Participants
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Abdominal Circumference
|
-1.39 cm
Standard Deviation 3.16
|
-2.98 cm
Standard Deviation 3.22
|
-2.42 cm
Standard Deviation 3.96
|
-2.62 cm
Standard Deviation 2.83
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
OPC-41061 7.5 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
OPC-41061 15 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
OPC-41061 30 mg
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
n=25 participants at risk
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
n=25 participants at risk
15 mg, 1 tablet a day
|
OPC-41061 30 mg
n=25 participants at risk
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Hepatobiliary disorders
Chronic Hepatitis
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Hepatobiliary disorders
Hepatic Failure
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Hepatobiliary disorders
Hepatorenal Syndrome
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Infections and infestations
Hepatitis B
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo, 1 tablet a day
|
OPC-41061 7.5 mg
n=25 participants at risk
7.5 mg, 1 tablet a day
|
OPC-41061 15 mg
n=25 participants at risk
15 mg, 1 tablet a day
|
OPC-41061 30 mg
n=25 participants at risk
30 mg, 1 tablet a day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/26 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Number of events 2 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
20.0%
5/25 • Number of events 7 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Number of events 2 • 7 days
|
20.0%
5/25 • Number of events 6 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
4.0%
1/25 • Number of events 4 • 7 days
|
|
General disorders
Thirst
|
3.8%
1/26 • Number of events 1 • 7 days
|
24.0%
6/25 • Number of events 6 • 7 days
|
56.0%
14/25 • Number of events 14 • 7 days
|
60.0%
15/25 • Number of events 15 • 7 days
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
General disorders
Pyrexia
|
11.5%
3/26 • Number of events 3 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
3/26 • Number of events 3 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.8%
1/26 • Number of events 1 • 7 days
|
24.0%
6/25 • Number of events 6 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Investigations
Blood Uric Acid Increased
|
3.8%
1/26 • Number of events 1 • 7 days
|
12.0%
3/25 • Number of events 4 • 7 days
|
16.0%
4/25 • Number of events 4 • 7 days
|
20.0%
5/25 • Number of events 5 • 7 days
|
|
Investigations
Blood Bilirubin Increased
|
19.2%
5/26 • Number of events 5 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
|
Investigations
Blood Osmolarity Increased
|
3.8%
1/26 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
16.0%
4/25 • Number of events 4 • 7 days
|
|
Investigations
Blood Urea Increased
|
15.4%
4/26 • Number of events 4 • 7 days
|
16.0%
4/25 • Number of events 4 • 7 days
|
16.0%
4/25 • Number of events 4 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
|
Investigations
Blood Creatinine Increased
|
11.5%
3/26 • Number of events 3 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
12.0%
3/25 • Number of events 3 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.5%
3/26 • Number of events 3 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Investigations
Blood Potassium Increased
|
7.7%
2/26 • Number of events 2 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/26 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
4.0%
1/25 • Number of events 3 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Investigations
Blood Sodium Increased
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Investigations
Blood Urine Present
|
0.00%
0/26 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/26 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Investigations
Blood Glucose Increased
|
7.7%
2/26 • Number of events 2 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/26 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
2/26 • Number of events 2 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • 7 days
|
8.0%
2/25 • Number of events 3 • 7 days
|
0.00%
0/25 • 7 days
|
4.0%
1/25 • Number of events 2 • 7 days
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
24.0%
6/25 • Number of events 6 • 7 days
|
24.0%
6/25 • Number of events 6 • 7 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/26 • 7 days
|
32.0%
8/25 • Number of events 8 • 7 days
|
20.0%
5/25 • Number of events 5 • 7 days
|
48.0%
12/25 • Number of events 12 • 7 days
|
|
Renal and urinary disorders
Renal Impairment
|
7.7%
2/26 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Number of events 1 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
2/26 • Number of events 2 • 7 days
|
4.0%
1/25 • Number of events 2 • 7 days
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
4.0%
1/25 • Number of events 1 • 7 days
|
0.00%
0/25 • 7 days
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place