Trial Outcomes & Findings for Phase II Dose-ranging Study of APD421 in PONV (NCT NCT01510704)
NCT ID: NCT01510704
Last Updated: 2019-03-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
24 hours
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Placebo
Single-dose IV placebo
|
Low Dose APD421
Single-dose 1 mg IV APD421
|
Mid Dose APD421
Single-dose 5 mg IV APD421
|
High Dose APD421
Single-dose 20 mg IV APD421
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
58
|
50
|
53
|
|
Overall Study
COMPLETED
|
54
|
58
|
50
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Dose-ranging Study of APD421 in PONV
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
|
Low Dose APD421
n=58 Participants
1mg dose level
|
Mid Dose APD421
n=50 Participants
5mg dose level
|
High Dose APD421
n=53 Participants
20mg dose level
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
50 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
50 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
49.9 years
STANDARD_DEVIATION 14.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
197 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: ITT
Outcome measures
| Measure |
Placebo
n=54 Participants
|
Low Dose APD421
n=58 Participants
1mg dose level
|
Mid Dose APD421
n=50 Participants
5mg dose level
|
High Dose APD421
n=53 Participants
20mg dose level
|
|---|---|---|---|---|
|
Post-operative Nausea or Vomiting
|
37 participants
|
28 participants
|
20 participants
|
30 participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Low Dose APD421
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Mid Dose APD421
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
High Dose APD421
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
|
Low Dose APD421
n=58 participants at risk
1mg dose level
|
Mid Dose APD421
n=50 participants at risk
5mg dose level
|
High Dose APD421
n=53 participants at risk
20mg dose level
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.00%
0/54
|
1.7%
1/58 • Number of events 1
|
0.00%
0/50
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.9%
1/54 • Number of events 1
|
0.00%
0/58
|
0.00%
0/50
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/54
|
0.00%
0/58
|
0.00%
0/50
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND HAEMATOMA
|
1.9%
1/54 • Number of events 1
|
0.00%
0/58
|
0.00%
0/50
|
0.00%
0/53
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
|
Low Dose APD421
n=58 participants at risk
1mg dose level
|
Mid Dose APD421
n=50 participants at risk
5mg dose level
|
High Dose APD421
n=53 participants at risk
20mg dose level
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
51.9%
28/54 • Number of events 28
|
51.7%
30/58 • Number of events 30
|
54.0%
27/50 • Number of events 27
|
50.9%
27/53 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
51.9%
28/54 • Number of events 28
|
32.8%
19/58 • Number of events 19
|
26.0%
13/50 • Number of events 13
|
45.3%
24/53 • Number of events 24
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
18/54 • Number of events 18
|
24.1%
14/58 • Number of events 14
|
14.0%
7/50 • Number of events 7
|
17.0%
9/53 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
11.1%
6/54 • Number of events 6
|
10.3%
6/58 • Number of events 6
|
12.0%
6/50 • Number of events 6
|
11.3%
6/53 • Number of events 6
|
|
Gastrointestinal disorders
Flatulence
|
13.0%
7/54 • Number of events 7
|
12.1%
7/58 • Number of events 7
|
8.0%
4/50 • Number of events 4
|
7.5%
4/53 • Number of events 4
|
|
General disorders
Pain
|
9.3%
5/54 • Number of events 5
|
12.1%
7/58 • Number of events 7
|
6.0%
3/50 • Number of events 3
|
11.3%
6/53 • Number of events 6
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
9.3%
5/54 • Number of events 5
|
6.9%
4/58 • Number of events 4
|
8.0%
4/50 • Number of events 4
|
9.4%
5/53 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/54 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
10.0%
5/50 • Number of events 5
|
7.5%
4/53 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place