Trial · NCT01395901
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
NCT01395901, Phase 3, Completed, Helsinn Healthcare SA; results first posted 2014-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients. Trials, record NCT01395901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
- NCT number
- NCT01395901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 670 participants, actual
- Lead sponsor
- Helsinn Healthcare SA
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Palonosetron, Ondansetron, Placebo to Ondansetron, Placebo to Palonosetron
- First posted
- 2011-07-18
- Last updated
- 2014-07-30
- Results first posted
- 2014-07-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Complete Response | 0-24 hours after T0 | 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. |
| Secondary | Proportion of Patients With no Vomiting | 0-24 hours after T0 | Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. |
| Secondary | Proportion of Patients Without Emetic Episodes | 0-24 hours after T0 | 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. |
| Secondary | Proportion of Patients Without Antiemetic Rescue Medication | 0-24 hours after T0 | 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. |
| Secondary | Proportion of Patients Without Nausea (Patient Aged > 6 Years) | 0-24 hours after T0 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Complete Response | 0-24 hours after T0 | 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. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients With no Vomiting | 0-24 hours after T0 | The Full Analysis Set (FAS) population. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Without Emetic Episodes | 0-24 hours after T0 | The Full Analysis Set (FAS) population. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Without Antiemetic Rescue Medication | 0-24 hours after T0 | The Full Analysis Set (FAS) population. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Without Nausea (Patient Aged > 6 Years) | 0-24 hours after T0 | The Full Analysis Set (FAS) population aged ≥ 6 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Complete Response | Palonosetron and Placebo to Ondansetron | 78.2 | 95% Confidence Interval 73.3 to 82.5 | percentage of patients | |
| Proportion of Patients With Complete Response | Ondansetron and Placebo to Palonosetron | 82.7 | 95% Confidence Interval 78.1 to 86.6 | percentage of patients | |
| Proportion of Patients With no Vomiting | Palonosetron and Placebo to Ondansetron | 83.1 | 95% Confidence Interval 78.5 to 86.9 | percentage of patients | |
| Proportion of Patients With no Vomiting | Ondansetron and Placebo to Palonosetron | 87.6 | 95% Confidence Interval 83.4 to 90.8 | percentage of patients | |
| Proportion of Patients Without Emetic Episodes | Palonosetron and Placebo to Ondansetron | 80.1 | 95% Confidence Interval 75.3 to 84.1 | percentage of patients | |
| Proportion of Patients Without Emetic Episodes | Ondansetron and Placebo to Palonosetron | 83.9 | 95% Confidence Interval 79.4 to 87.6 | percentage of patients | |
| Proportion of Patients Without Antiemetic Rescue Medication | Palonosetron and Placebo to Ondansetron | 93.1 | 95% Confidence Interval 89.6 to 95.4 | percentage of patients | |
| Proportion of Patients Without Antiemetic Rescue Medication | Ondansetron and Placebo to Palonosetron | 96.4 | 95% Confidence Interval 93.6 to 98.0 | percentage of patients | |
| Proportion of Patients Without Nausea (Patient Aged > 6 Years) | Palonosetron and Placebo to Ondansetron | 83.2 | 95% Confidence Interval 76.9 to 88.2 | percentage of patients | |
| Proportion of Patients Without Nausea (Patient Aged > 6 Years) | Ondansetron and Placebo to Palonosetron | 82.0 | 95% Confidence Interval 75.5 to 87.1 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palonosetron and Placebo to Ondansetron | 336 | |
| Overall Study | STARTED | Ondansetron and Placebo to Palonosetron | 334 | |
| Overall Study | COMPLETED | Palonosetron and Placebo to Ondansetron | 326 | |
| Overall Study | COMPLETED | Ondansetron and Placebo to Palonosetron | 329 | |
| Overall Study | NOT COMPLETED | Palonosetron and Placebo to Ondansetron | 10 | |
| Overall Study | NOT COMPLETED | Ondansetron and Placebo to Palonosetron | 5 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pain | Injury, poisoning and procedural complications | Palonosetron and Placebo to Ondansetron | 147 | 331 | 149 |
| other | Procedural pain | Injury, poisoning and procedural complications | Ondansetron and Placebo to Palonosetron | 123 | 330 | 126 |
| other | Pyrexia | General disorders | Palonosetron and Placebo to Ondansetron | 22 | 331 | 22 |
| other | Pyrexia | General disorders | Ondansetron and Placebo to Palonosetron | 25 | 330 | 30 |
| other | Pain | General disorders | Palonosetron and Placebo to Ondansetron | 15 | 331 | 16 |
| other | Pain | General disorders | Ondansetron and Placebo to Palonosetron | 15 | 330 | 16 |
| other | Hyperthermia | General disorders | Palonosetron and Placebo to Ondansetron | 2 | 331 | 2 |
| other | Hyperthermia | General disorders | Ondansetron and Placebo to Palonosetron | 12 | 330 | 19 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Palonosetron and Placebo to Ondansetron | 27 | 331 | 28 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Ondansetron and Placebo to Palonosetron | 37 | 330 | 39 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palonosetron and Placebo to Ondansetron | ||
| Total, all-cause mortality | Ondansetron and Placebo to Palonosetron | ||
| Total, other adverse events | Palonosetron and Placebo to Ondansetron | 234 | 331 |
| Total, other adverse events | Ondansetron and Placebo to Palonosetron | 225 | 330 |
| Total, serious adverse events | Palonosetron and Placebo to Ondansetron | 4 | 331 |
| Total, serious adverse events | Ondansetron and Placebo to Palonosetron | 11 | 330 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Palonosetron and Placebo to Ondansetron vs Ondansetron and Placebo to Palonosetron: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01395901
GET https://conductscience.org/api/trials/v1/NCT01395901/events?page=2