Trial Outcomes & Findings for Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients (NCT NCT00828295)
NCT ID: NCT00828295
Last Updated: 2015-04-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
0-72 hours post-operatively
Results posted on
2015-04-03
Participant Flow
First patient enrolled: 19 August 2008. Last patient completed: 27 December 2008. A total of 12 Investigators from two countries (Russia and Ukraine) participated in the study. The study was conducted at 4 sites in Russia and 8 sites in Ukraine.
Participant milestones
| Measure |
1 mcg/kg Arm
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg
|
3 mcg/kg Arm
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Baseline characteristics by cohort
| Measure |
1 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg
|
3 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<2 years
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age, Customized
2 to <6 years
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Age, Customized
6 to <12 years
|
29 participants
n=5 Participants
|
33 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age, Customized
12 to <17 years
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-72 hours post-operativelyPopulation: The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.
Outcome measures
| Measure |
1 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg
|
3 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV
|
|---|---|---|
|
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
|
88.0 percentage of patients
Interval 78.4 to 94.4
|
84.0 percentage of patients
Interval 73.7 to 91.4
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: Full Analysis Set
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Outcome measures
| Measure |
1 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg
|
3 mcg/kg Arm
n=75 Participants
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV
|
|---|---|---|
|
Proportion of Patients With Complete Response 0-24 Hours
|
88.0 percentage of patients
Interval 78.4 to 94.4
|
84.0 percentage of patients
Interval 73.7 to 91.4
|
Adverse Events
1 mcg/kg Arm
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
3 mcg/kg Arm
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 mcg/kg Arm
n=74 participants at risk
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg
|
3 mcg/kg Arm
n=76 participants at risk
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
27.0%
20/74 • Number of events 20 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
25.0%
19/76 • Number of events 19 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
5/74 • Number of events 5 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
2.6%
2/76 • Number of events 2 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/74 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
5.3%
4/76 • Number of events 6 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
General disorders
Asthenia
|
1.4%
1/74 • Number of events 1 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
3.9%
3/76 • Number of events 3 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
General disorders
Pyrexia
|
1.4%
1/74 • Number of events 1 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
2.6%
2/76 • Number of events 2 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/74 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
5.3%
4/76 • Number of events 6 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/74 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
6.6%
5/76 • Number of events 7 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Nervous system disorders
Dizziness
|
2.7%
2/74 • Number of events 2 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
1.3%
1/76 • Number of events 1 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/74 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
2.6%
2/76 • Number of events 2 • During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.
Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place