Trial Outcomes & Findings for A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema (NCT NCT01114828)
NCT ID: NCT01114828
Last Updated: 2014-03-04
Results Overview
Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Bseline, Day 7 or at the discontined of treatment
Results posted on
2014-03-04
Participant Flow
Participant milestones
| Measure |
3.75 mg
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
7.5 mg
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
3.75 mg
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
7.5 mg
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
Baseline characteristics by cohort
| Measure |
3.75 mg
n=19 Participants
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
7.5 mg
n=21 Participants
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Bseline, Day 7 or at the discontined of treatmentPopulation: For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.
Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.
Outcome measures
| Measure |
OPC-41061 3.75 mg
n=16 Participants
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
OPC-41061 7.5 mg
n=20 Participants
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Body Weight
|
-1.14 kg
Standard Deviation 0.86
|
-1.37 kg
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Baseline, Day 7 or at the discontinued of treatmentPopulation: For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.
Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.
Outcome measures
| Measure |
OPC-41061 3.75 mg
n=16 Participants
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
OPC-41061 7.5 mg
n=20 Participants
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Ascites Volume as Measured by CT
|
-407.5 mL
Standard Deviation 545.8
|
-514.0 mL
Standard Deviation 993.8
|
Adverse Events
3.75 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
7.5 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.75 mg
n=19 participants at risk
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
7.5 mg
n=21 participants at risk
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia Haemorrhagic
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
5.3%
1/19 • Number of events 1 • 7 days
|
9.5%
2/21 • Number of events 2 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
Other adverse events
| Measure |
3.75 mg
n=19 participants at risk
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
|
7.5 mg
n=21 participants at risk
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Cardiac disorders
Wolff-Parkinson-White Syndrome
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Dry Mouth
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 4 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • 7 days
|
0.00%
0/21 • 7 days
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Number of events 2 • 7 days
|
4.8%
1/21 • Number of events 2 • 7 days
|
|
General disorders
Thirst
|
15.8%
3/19 • Number of events 3 • 7 days
|
33.3%
7/21 • Number of events 7 • 7 days
|
|
Hepatobiliary disorders
Pylethrombosis
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Infections and infestations
Colitis Pseudomembranous
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Infections and infestations
Infection
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.5%
2/19 • Number of events 2 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Alanine Aminotransferase Increased
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
10.5%
2/19 • Number of events 2 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Investigations
Blood Potassium Increased
|
10.5%
2/19 • Number of events 3 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Pressure Decreased
|
15.8%
3/19 • Number of events 4 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Sodium Decreased
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
Blood Urea Increased
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Investigations
Blood Urine Present
|
10.5%
2/19 • Number of events 2 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Investigations
Prothrombin Time Prolonged
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.5%
2/19 • Number of events 2 • 7 days
|
0.00%
0/21 • 7 days
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/19 • 7 days
|
9.5%
2/21 • Number of events 2 • 7 days
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Renal and urinary disorders
Renal Impairment
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • 7 days
|
0.00%
0/21 • 7 days
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
15.8%
3/19 • Number of events 3 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/19 • 7 days
|
4.8%
1/21 • Number of events 1 • 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