Trial Outcomes & Findings for A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema (NCT NCT01050530)
NCT ID: NCT01050530
Last Updated: 2014-03-04
Results Overview
Change in body weight from baseline after 7-day repeated oral administration of OPC
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
162 participants
Primary outcome timeframe
Baseline, Day 7 or at the discontinued of treatment
Results posted on
2014-03-04
Participant Flow
Participant milestones
| Measure |
OPC-41061
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
80
|
|
Overall Study
COMPLETED
|
74
|
70
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
OPC-41061
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
Baseline characteristics by cohort
| Measure |
OPC-41061
n=82 Participants
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
n=80 Participants
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
82 participants
n=5 Participants
|
80 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7 or at the discontinued of treatmentPopulation: Full Analysis Set; LOCF
Change in body weight from baseline after 7-day repeated oral administration of OPC
Outcome measures
| Measure |
OPC-41061
n=82 Participants
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
n=80 Participants
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Body ｗeight
|
-1.95 Kg
Standard Deviation 1.77
|
-0.44 Kg
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Baseline, Day 7 or at the discontinued of treatmentPopulation: Full Analysis Set; LOCF
Change in ascites volume from baseline as measured by CT at end of treatment
Outcome measures
| Measure |
OPC-41061
n=82 Participants
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
n=80 Participants
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Ascites Volume
|
-492.4 mL
Standard Deviation 760.3
|
-191.8 mL
Standard Deviation 690.8
|
Adverse Events
OPC-41061
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-41061
n=82 participants at risk
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
n=80 participants at risk
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/82 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.00%
0/82 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Hepatobiliary disorders
Pylethrombosis
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Infections and infestations
Omphalitis
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/82 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/82 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Nervous system disorders
Coma Hepatic
|
0.00%
0/82 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
1.2%
1/82 • Number of events 1 • 7 days
|
3.8%
3/80 • Number of events 3 • 7 days
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/82 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Renal and urinary disorders
Renal Impairment
|
1.2%
1/82 • Number of events 1 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiration Failure
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
|
Vascular disorders
Intra-Abdominal Haemorrhage
|
1.2%
1/82 • Number of events 1 • 7 days
|
0.00%
0/80 • 7 days
|
Other adverse events
| Measure |
OPC-41061
n=82 participants at risk
OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Placebo
n=80 participants at risk
Placebo: Once-daily oral administration of placebo after breakfast for 7 days
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.3%
6/82 • Number of events 6 • 7 days
|
7.5%
6/80 • Number of events 6 • 7 days
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
6/82 • Number of events 6 • 7 days
|
5.0%
4/80 • Number of events 4 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
4/82 • Number of events 5 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
|
Gastrointestinal disorders
Stomatitis
|
3.7%
3/82 • Number of events 3 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
General disorders
Thirst
|
13.4%
11/82 • Number of events 12 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
|
General disorders
Pyrexia
|
4.9%
4/82 • Number of events 4 • 7 days
|
7.5%
6/80 • Number of events 7 • 7 days
|
|
Investigations
Blood Urea Increased
|
1.2%
1/82 • Number of events 1 • 7 days
|
5.0%
4/80 • Number of events 4 • 7 days
|
|
Investigations
Hyperammonaemia
|
2.4%
2/82 • Number of events 2 • 7 days
|
3.8%
3/80 • Number of events 3 • 7 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
3.7%
3/82 • Number of events 3 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
|
Psychiatric disorders
Insomnia
|
4.9%
4/82 • Number of events 4 • 7 days
|
0.00%
0/80 • 7 days
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
6/82 • Number of events 6 • 7 days
|
0.00%
0/80 • 7 days
|
|
Renal and urinary disorders
Renal Impairment
|
6.1%
5/82 • Number of events 5 • 7 days
|
6.2%
5/80 • Number of events 5 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/82 • 7 days
|
3.8%
3/80 • Number of events 3 • 7 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
3/82 • Number of events 3 • 7 days
|
0.00%
0/80 • 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