Trial Outcomes & Findings for Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy (NCT NCT00888329)
NCT ID: NCT00888329
Last Updated: 2012-03-30
Results Overview
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
256 participants
Primary outcome timeframe
24 hours after emergence from anesthesia
Results posted on
2012-03-30
Participant Flow
Enrollment began July 2007. Enrollment stopped October 2011 due to slow accrual.
Participant milestones
| Measure |
Aprepitant
40 mg aprepitant
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
131
|
|
Overall Study
COMPLETED
|
119
|
122
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Aprepitant
40 mg aprepitant
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
6
|
9
|
Baseline Characteristics
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
Baseline characteristics by cohort
| Measure |
Aprepitant
n=50 Participants
40 mg aprepitant
|
Placebo
n=70 Participants
Placebo
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60 years
STANDARD_DEVIATION 12 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after emergence from anesthesiaPopulation: ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
Outcome measures
| Measure |
Aprepitant
n=35 Participants
40 mg aprepitant
|
Placebo
n=59 Participants
Placebo
|
|---|---|---|
|
Number of Participants With Emesis
|
6 participants
|
17 participants
|
Adverse Events
Aprepitant
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant
n=34 participants at risk
40 mg aprepitant
|
Placebo
n=37 participants at risk
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
2.9%
1/34 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Blood and lymphatic system disorders
blood clot in leg
|
2.9%
1/34 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Infections and infestations
hospital-aquired pneumonia
|
2.9%
1/34 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Injury, poisoning and procedural complications
intestinal perforation
|
0.00%
0/34 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
|
Infections and infestations
wound infection
|
2.9%
1/34 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
Other adverse events
| Measure |
Aprepitant
n=34 participants at risk
40 mg aprepitant
|
Placebo
n=37 participants at risk
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
5.9%
2/34 • 6 weeks
|
5.4%
2/37 • 6 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/34 • 6 weeks
|
5.4%
2/37 • 6 weeks
|
|
Nervous system disorders
headache
|
5.9%
2/34 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
|
Endocrine disorders
hot flashes
|
5.9%
2/34 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
|
Gastrointestinal disorders
nausea
|
5.9%
2/34 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
|
Nervous system disorders
paresthesia
|
5.9%
2/34 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/34 • 6 weeks
|
5.4%
2/37 • 6 weeks
|
|
Infections and infestations
urinary tract infection
|
2.9%
1/34 • 6 weeks
|
16.2%
6/37 • 6 weeks
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
5.9%
2/34 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Infections and infestations
wound infection
|
17.6%
6/34 • 6 weeks
|
13.5%
5/37 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place