Postoperative Nausea and VomitingPhase 3NCT00828295
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
A Phase 3 study testing palonosetron in people with Postoperative Nausea and Vomiting, run by Helsinn Healthcare SA at 13 sites in 2 countries.
Trial summary
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general… Read more about this study
- Who is it for?
- Ages 28 days to 16 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 16 years
- All sexes
- No healthy volunteers
- Child
MAIN INCLUSION CRITERIA
- Male or female patient aged more than 28 days (full term) up to and including 16 years.
- Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:
- ear, nose and throat surgery;
- eye surgery;
- orchidopexy;
- plastic reconstructive surgery;
- herniorraphy;
- orthopedic surgery).
- American Society of Anesthesiologists (ASA) physical status I, II or III.
- Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
- Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
- For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.
MAIN EXCLUSION CRITERIA
- For infant aged more than 12 months: a history of gastro-esophageal reflux.
- For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
- Patient scheduled to undergo emergency surgery.
- Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
- Patient scheduled to receive propofol during the maintenance phase of anesthesia.
- Patient with vomiting from any organic cause.
- Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
- Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Ukraine8 sites
Cherkassy Regional Hospital, Pediatric Surgery Department
Cherkassy
Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
Dnipropetrovsk
M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
Donetsk
Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
Ivano-Frankivsk
Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
Kyiv
Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department
Kyiv
Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
Kyiv
Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
Lviv
Russia5 sites
Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
Moscow
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
Moscow
Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
Saint Petersburg
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
Saint Petersburg
State Healthcare Institution 'Regional Pediatric Clinical Hospital'
Yaroslavl
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- palonosetron
- Keywords
- Postoperative Nausea and Vomiting, palonosetron, pediatric
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetronDrug
palonosetron IV 1 mcg/kg
palonosetronDrug
palonosetron 3mcg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| 1 mcg/kg arm | Experimental | Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) Receives: Drug: palonosetron |
| 3 mcg/kg arm | Experimental | Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg) Receives: Drug: palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Measured: 0-72 hours post-operatively
Secondary outcomes (1)
Proportion of Patients With Complete Response 0-24 Hours
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828295
- Sponsor's protocol ID
- PALO-07-29
- Status last verified
- Jul 2014
- First submitted
- 22 Jan 2009
- Last updated
- 3 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00828295
- Acronym / sponsor ID
- PALO-07-29
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, palonosetron, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mcg/kg arm | Experimental | Drug: palonosetronSingle dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) |
| 3 mcg/kg arm | Experimental | Drug: palonosetronSingle dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg) |
Who may qualify
- Ages
- 28 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palonosetronpalonosetron IV 1 mcg/kg | Drug | 1 mcg/kg arm |
| palonosetronpalonosetron 3mcg/kg IV | Drug | 3 mcg/kg arm |
Primary outcome
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Time frame: 0-72 hours post-operatively
1 secondary outcome
Proportion of Patients With Complete Response 0-24 Hours
Time frame: 0-24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing palonosetron in people with Postoperative Nausea and Vomiting, run by Helsinn Healthcare SA at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively (time frame: 0-72 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.