Trial Outcomes & Findings for Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV) (NCT NCT00895830)
NCT ID: NCT00895830
Last Updated: 2011-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
24 hours
Results posted on
2011-03-29
Participant Flow
Participant milestones
| Measure |
Placebo
|
APD405 0.3mg Dose
|
APD405 1mg Dose
|
APD405 2mg Dose
|
APD405 3mg Dose
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
49
|
52
|
55
|
|
Overall Study
COMPLETED
|
51
|
50
|
49
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
|
APD405 0.3mg Dose
n=50 Participants
|
APD405 1mg Dose
n=49 Participants
|
APD405 2mg Dose
n=52 Participants
|
APD405 3mg Dose
n=55 Participants
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
51.2 years
STANDARD_DEVIATION 13.828 • n=93 Participants
|
49.4 years
STANDARD_DEVIATION 13.575 • n=4 Participants
|
49.5 years
STANDARD_DEVIATION 13.949 • n=27 Participants
|
52.3 years
STANDARD_DEVIATION 16.191 • n=483 Participants
|
50.3 years
STANDARD_DEVIATION 13.599 • n=36 Participants
|
50.55 years
STANDARD_DEVIATION 14.198 • n=10 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
231 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
26 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
7 participants
n=4 Participants
|
9 participants
n=27 Participants
|
6 participants
n=483 Participants
|
9 participants
n=36 Participants
|
39 participants
n=10 Participants
|
|
Region of Enrollment
France
|
16 participants
n=93 Participants
|
15 participants
n=4 Participants
|
14 participants
n=27 Participants
|
16 participants
n=483 Participants
|
16 participants
n=36 Participants
|
77 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=93 Participants
|
28 participants
n=4 Participants
|
26 participants
n=27 Participants
|
29 participants
n=483 Participants
|
29 participants
n=36 Participants
|
138 participants
n=10 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
3 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: ITT
Outcome measures
| Measure |
Placebo
n=51 Participants
|
APD405 0.3mg Dose
n=50 Participants
|
APD405 1mg Dose
n=49 Participants
|
APD405 2mg Dose
n=52 Participants
|
APD405 3mg Dose
n=55 Participants
|
|---|---|---|---|---|---|
|
Experienced Post-operative Nausea or Vomiting
|
25 participants
|
29 participants
|
20 participants
|
30 participants
|
28 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
APD405 0.3mg Dose
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
APD405 1mg Dose
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
APD405 2mg Dose
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
APD405 3mg Dose
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
|
APD405 0.3mg Dose
n=50 participants at risk
|
APD405 1mg Dose
n=49 participants at risk
|
APD405 2mg Dose
n=52 participants at risk
|
APD405 3mg Dose
n=55 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/49
|
1.9%
1/52 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Impaired healing
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/49
|
1.9%
1/52 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/49
|
0.00%
0/52
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post-procedural haemorrhage
|
0.00%
0/51
|
2.0%
1/50 • Number of events 1
|
0.00%
0/49
|
0.00%
0/52
|
0.00%
0/55
|
|
Injury, poisoning and procedural complications
Post-operative ileus
|
0.00%
0/51
|
0.00%
0/50
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/55
|
|
Investigations
Blood calcium decreased
|
0.00%
0/51
|
0.00%
0/50
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/55
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/49
|
0.00%
0/52
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/49
|
0.00%
0/52
|
1.8%
1/55 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
|
APD405 0.3mg Dose
n=50 participants at risk
|
APD405 1mg Dose
n=49 participants at risk
|
APD405 2mg Dose
n=52 participants at risk
|
APD405 3mg Dose
n=55 participants at risk
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
47.1%
24/51
|
50.0%
25/50
|
65.3%
32/49
|
48.1%
25/52
|
43.6%
24/55
|
|
Gastrointestinal disorders
Nausea
|
51.0%
26/51
|
56.0%
28/50
|
40.8%
20/49
|
57.7%
30/52
|
45.5%
25/55
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
15/51
|
26.0%
13/50
|
26.5%
13/49
|
42.3%
22/52
|
32.7%
18/55
|
|
Gastrointestinal disorders
Flatulence
|
9.8%
5/51
|
14.0%
7/50
|
14.3%
7/49
|
13.5%
7/52
|
7.3%
4/55
|
|
Psychiatric disorders
Insomnia
|
11.8%
6/51
|
6.0%
3/50
|
16.3%
8/49
|
13.5%
7/52
|
10.9%
6/55
|
|
Gastrointestinal disorders
Constipation
|
7.8%
4/51
|
10.0%
5/50
|
10.2%
5/49
|
7.7%
4/52
|
9.1%
5/55
|
|
Vascular disorders
Hypertension
|
3.9%
2/51
|
0.00%
0/50
|
2.0%
1/49
|
7.7%
4/52
|
7.3%
4/55
|
|
Investigations
Hyp0kalaemia
|
5.9%
3/51
|
2.0%
1/50
|
6.1%
3/49
|
5.8%
3/52
|
0.00%
0/55
|
|
Nervous system disorders
Headache
|
2.0%
1/51
|
2.0%
1/50
|
8.2%
4/49
|
7.7%
4/52
|
0.00%
0/55
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51
|
2.0%
1/50
|
4.1%
2/49
|
5.8%
3/52
|
3.6%
2/55
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place