Trial Outcomes & Findings for Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients (NCT NCT01395901)
NCT ID: NCT01395901
Last Updated: 2014-07-30
Results Overview
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
670 participants
Primary outcome timeframe
0-24 hours after T0
Results posted on
2014-07-30
Participant Flow
A total of 44 sites were initiated in seven countries with 12, 9, 5, 5, 5, 6 and 2 investigative sites in the United States, Ukraine, Hungary, Poland, Russia, Czech Republic and Argentina. Patients were enrolled into the study by 39 out of 44 Investigators enrolling at least one patient.
Participant milestones
| Measure |
Palonosetron and Placebo to Ondansetron
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Overall Study
STARTED
|
336
|
334
|
|
Overall Study
COMPLETED
|
326
|
329
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Palonosetron and Placebo to Ondansetron
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Randomized but not received study drug
|
5
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<2 years
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
2 <6 years
|
124 participants
n=5 Participants
|
123 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Age, Customized
6 <12 years
|
117 participants
n=5 Participants
|
117 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Age, Customized
12 <17 years
|
68 participants
n=5 Participants
|
66 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
307 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
616 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
315 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
627 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hours after T0Population: The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Outcome measures
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Proportion of Patients With Complete Response
|
78.2 percentage of patients
Interval 73.3 to 82.5
|
82.7 percentage of patients
Interval 78.1 to 86.6
|
SECONDARY outcome
Timeframe: 0-24 hours after T0Population: The Full Analysis Set (FAS) population.
Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Outcome measures
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Proportion of Patients With no Vomiting
|
83.1 percentage of patients
Interval 78.5 to 86.9
|
87.6 percentage of patients
Interval 83.4 to 90.8
|
SECONDARY outcome
Timeframe: 0-24 hours after T0Population: The Full Analysis Set (FAS) population.
An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Outcome measures
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Proportion of Patients Without Emetic Episodes
|
80.1 percentage of patients
Interval 75.3 to 84.1
|
83.9 percentage of patients
Interval 79.4 to 87.6
|
SECONDARY outcome
Timeframe: 0-24 hours after T0Population: The Full Analysis Set (FAS) population.
Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Outcome measures
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Proportion of Patients Without Antiemetic Rescue Medication
|
93.1 percentage of patients
Interval 89.6 to 95.4
|
96.4 percentage of patients
Interval 93.6 to 98.0
|
SECONDARY outcome
Timeframe: 0-24 hours after T0Population: The Full Analysis Set (FAS) population aged ≥ 6 years
Outcome measures
| Measure |
Palonosetron and Placebo to Ondansetron
n=185 Participants
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=183 Participants
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Proportion of Patients Without Nausea (Patient Aged > 6 Years)
|
83.2 percentage of patients
Interval 76.9 to 88.2
|
82.0 percentage of patients
Interval 75.5 to 87.1
|
Adverse Events
Palonosetron and Placebo to Ondansetron
Serious events: 4 serious events
Other events: 234 other events
Deaths: 0 deaths
Ondansetron and Placebo to Palonosetron
Serious events: 11 serious events
Other events: 225 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 participants at risk
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 participants at risk
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.30%
1/331 • Number of events 1
|
1.5%
5/330 • Number of events 6
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/331 • Number of events 1
|
0.30%
1/330 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Gastrointestinal disorders
Hernial eventration
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Gastrointestinal disorders
Ileus
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/331 • Number of events 1
|
0.61%
2/330 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
General disorders
Pyrexia
|
0.30%
1/331 • Number of events 1
|
0.00%
0/330
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/331
|
0.30%
1/330 • Number of events 1
|
Other adverse events
| Measure |
Palonosetron and Placebo to Ondansetron
n=331 participants at risk
Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron
|
Ondansetron and Placebo to Palonosetron
n=330 participants at risk
Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
44.4%
147/331 • Number of events 149
|
37.3%
123/330 • Number of events 126
|
|
General disorders
Pyrexia
|
6.6%
22/331 • Number of events 22
|
7.6%
25/330 • Number of events 30
|
|
General disorders
Pain
|
4.5%
15/331 • Number of events 16
|
4.5%
15/330 • Number of events 16
|
|
General disorders
Hyperthermia
|
0.60%
2/331 • Number of events 2
|
3.6%
12/330 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
27/331 • Number of events 28
|
11.2%
37/330 • Number of events 39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
7/331 • Number of events 7
|
1.5%
5/330 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
5/331 • Number of events 5
|
3.0%
10/330 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.60%
2/331 • Number of events 2
|
2.4%
8/330 • Number of events 8
|
|
Nervous system disorders
Headache
|
1.2%
4/331 • Number of events 4
|
3.0%
10/330 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Scar
|
2.1%
7/331 • Number of events 7
|
1.2%
4/330 • Number of events 4
|
|
Ear and labyrinth disorders
Ear pain
|
1.8%
6/331 • Number of events 6
|
2.7%
9/330 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If Sponsor does not submit a publication regarding the study to a journal within 12 months from study data analysis completion, the Investigator may publish an analysis of the study data collected as a result of the conduct of the study by the Investigator. The Investigator shall ensure that at least 60 days prior to submitting/presenting a manuscript/material relating to study to publishers a copy of all manuscripts/materials is provided to the Sponsor to allow the Sponsor sixty days to review.
- Publication restrictions are in place
Restriction type: OTHER