Trial Outcomes & Findings for A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg (NCT NCT01048788)
NCT ID: NCT01048788
Last Updated: 2016-04-11
Results Overview
Changes in body weight from baseline at the end of administration
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
Baseline, Day 14 or end of administration
Results posted on
2016-04-11
Participant Flow
Participant milestones
| Measure |
Discontinued/Terminated Before Day8
Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
Subjects who met the criteria for dose escalation
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
30
|
13
|
|
Overall Study
COMPLETED
|
3
|
28
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
2
|
Reasons for withdrawal
| Measure |
Discontinued/Terminated Before Day8
Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
Subjects who met the criteria for dose escalation
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
Baseline characteristics by cohort
| Measure |
Discontinued/Terminated Before Day8
n=8 Participants
Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
n=30 Participants
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
n=13 Participants
Subjects who met the criteria for dose escalation
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.9 • n=4 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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=5 Participants
|
30 participants
n=7 Participants
|
13 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14 or end of administrationChanges in body weight from baseline at the end of administration
Outcome measures
| Measure |
Discontitued/Terminated Before Day 8
n=8 Participants
Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
n=30 Participants
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
n=13 Participants
Subjects who met the criteria for dose escalation
|
|---|---|---|---|
|
Body Weight
|
-0.76 Kg
Standard Deviation 0.93
|
-2.97 Kg
Standard Deviation 2.57
|
-0.05 Kg
Standard Deviation 2.30
|
Adverse Events
Discontinued/Terminated Before Day8
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Continued Administration at 7.5 mg/Day
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Dose Escalation to 15 mg/Day
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Discontinued/Terminated Before Day8
n=8 participants at risk
Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
n=30 participants at risk
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
n=13 participants at risk
Subjects who met the criteria for dose escalation
|
|---|---|---|---|
|
Ear and labyrinth disorders
Positional Vertigo
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • 14 days
|
3.3%
1/30 • Number of events 1 • 14 days
|
0.00%
0/13 • 14 days
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.00%
0/8 • 14 days
|
3.3%
1/30 • Number of events 1 • 14 days
|
0.00%
0/13 • 14 days
|
|
General disorders
Hernia Obstructive
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 14 days
|
3.3%
1/30 • Number of events 1 • 14 days
|
0.00%
0/13 • 14 days
|
|
Infections and infestations
Peritonitis Bacterial
|
0.00%
0/8 • 14 days
|
0.00%
0/30 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Infections and infestations
Septicaemia
|
0.00%
0/8 • 14 days
|
0.00%
0/30 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Nervous system disorders
Diabetic Neuropathy
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
12.5%
1/8 • Number of events 1 • 14 days
|
3.3%
1/30 • Number of events 1 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Nervous system disorders
Polyneuropathy Alcoholic
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
Other adverse events
| Measure |
Discontinued/Terminated Before Day8
n=8 participants at risk
Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
|
Continued Administration at 7.5 mg/Day
n=30 participants at risk
Subjects who did not meet the criteria for dose escalation
|
Dose Escalation to 15 mg/Day
n=13 participants at risk
Subjects who met the criteria for dose escalation
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
12.5%
1/8 • Number of events 1 • 14 days
|
3.3%
1/30 • Number of events 1 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 14 days
|
13.3%
4/30 • Number of events 4 • 14 days
|
0.00%
0/13 • 14 days
|
|
General disorders
Malaise
|
0.00%
0/8 • 14 days
|
0.00%
0/30 • 14 days
|
15.4%
2/13 • Number of events 2 • 14 days
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • 14 days
|
10.0%
3/30 • Number of events 3 • 14 days
|
15.4%
2/13 • Number of events 2 • 14 days
|
|
General disorders
Thirst
|
12.5%
1/8 • Number of events 1 • 14 days
|
33.3%
10/30 • Number of events 10 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/8 • 14 days
|
13.3%
4/30 • Number of events 5 • 14 days
|
0.00%
0/13 • 14 days
|
|
Investigations
Blood Pressure Decreased
|
12.5%
1/8 • Number of events 1 • 14 days
|
10.0%
3/30 • Number of events 4 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Investigations
Blood Urea Increased
|
12.5%
1/8 • Number of events 1 • 14 days
|
10.0%
3/30 • Number of events 3 • 14 days
|
0.00%
0/13 • 14 days
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 14 days
|
10.0%
3/30 • Number of events 4 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 14 days
|
0.00%
0/30 • 14 days
|
15.4%
2/13 • Number of events 3 • 14 days
|
|
Psychiatric disorders
Delirium
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • 14 days
|
13.3%
4/30 • Number of events 4 • 14 days
|
15.4%
2/13 • Number of events 2 • 14 days
|
|
Renal and urinary disorders
Bladder Dysfunction
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Renal and urinary disorders
Renal Impairment
|
12.5%
1/8 • Number of events 1 • 14 days
|
6.7%
2/30 • Number of events 2 • 14 days
|
0.00%
0/13 • 14 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • 14 days
|
0.00%
0/30 • 14 days
|
0.00%
0/13 • 14 days
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/8 • 14 days
|
0.00%
0/30 • 14 days
|
7.7%
1/13 • Number of events 1 • 14 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