Postoperative Nausea and VomitingPhase 3NCT01395901
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
A Phase 3 study testing Palonosetron and Ondansetron in people with Postoperative Nausea and Vomiting, run by Helsinn Healthcare SA at 44 sites in 8 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Palonosetron and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 44 sitesin 8 countries
- Study dates
- Jun 2011to Apr 2012
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patient aged from full term neonate to less than 17 years.
- In-patient or out-patient scheduled to undergo one of the following procedures:
- ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
- eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
- urological surgery (e.g. orchidopexy, varicocoele),
- plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
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- hernia repair,
- orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),.
- cardiac surgery,
- neurosurgery.
- Patient is scheduled to undergo surgery requiring general intravenous anesthesia
- Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia
- Patient weighs at least 3.2 kg
- ASA physical status I, II or III
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2)
- For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
Who cannot join
- Lactating females
- Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
- Patient having participated in any previous trial with palonosetron.
- History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
- Patient to undergo emergency surgery
- Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia
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- Patient scheduled to receive laryngeal mask anesthesia
- Patient scheduled to receive propofol during the maintenance phase of anesthesia
- Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery
- Patient with history of gastro-esophageal reflux (except for patients up to 12 months)
- Patient with ongoing vomiting from any organic cause
- Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug
Trial locations and contacts
44 sites in 8 countries.
44 sites in 8 countries
United States12 sites
Cooper University Hospital
Camden, New Jersey, 08103
The University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Clinical Trial Developers
Cincinnati, Ohio, 45255
Duke University Medical Center
Durham, North Carolina, 27710
Shoals Clinical Research Associates
Florence, Alabama, 35630
Texas Orthopedic Specialist, P.A
Grapevine, Texas, 76051
Memorial Hermann Hospital
Houston, Texas, 77030
CRC of Jackson
Jackson, Mississippi, 39202
Bascom Palmer Eye Institute - University of Miami
Miami, Florida, 33136
Shoals Medical Research, LLC
Sheffield, Alabama, 35660
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Ukraine8 sites
Dnipropetrovsk Regional Childrens Clinical Hospital
Dnipropetrovsk, 49100
Regional Childrens Clinical Hospital
Donetsk, 83052
Ivano-Frankivsk Regional Childrens Clinical Hospital
Ivano-Frankivsk, 76000
City Clinical Hospital n#30
Kharkiv, 61000
Research and Development Center for Prophylactic and Clinical Medicine
Kyiv, 01133
National Specialized Childrens Hospital OKHMATDYT
Kyiv, 01135
V.P. Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061
Zaporizhia Regional Clinical Childrens Hospital
Zaporizhia, 69000
Czechia6 sites
University Hospital Brno - Children's Medical Centre
Brno, 61300
University Hospital Hradec Kralove
Hradec Králové, 500 05
University Hospital Olomouc
Olomouc, 775 20
University Hospital Pilsen- Paediatric Clinic
Plzen-Lochotin, 30460
University Hospital Motol
Prague, 15006
Hospital Znojmo, State-Funded Organisation, Department of Pediatrics
Znojmo, 669 02
Hungary5 sites
Semmeleis University
Budapest, 1083
St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit
Budapest, 1097
The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit
Budapest, 1125
St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit
Dunaújváros, 2400
Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit
Gyula, 5700
Poland5 sites
Department of Pediatric Surgery and Urology of Medical University of Gdansk
Gdansk, 80-803
Department of Pediatric Anesthesiology and Intensive Care
Lodz, 91-738
Department of Pediatric Anesthesiology and Intensive Care
Lublin, 20-093
Department of Intensive Care and Anesthesiology
Olsztyn, 10-561
Department of Pediatric Surgery
Wroclaw, 50-369
Russia5 sites
State Healthcare Institution Arkhangelsk Regional Children's Hospital
Arkhangelsk, 132002
Federal State Institution: St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the MoH Care and Social Development of the Russian Federation
Saint Petersburg, 190013
International Clinic MEDEM
Saint Petersburg, 191025
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100
Yaroslavl Region State Healthcare Institution
Yaroslavl, 150042
Argentina2 sites
CEMIC, Otorhinolaryngology Department
Buenos Aires, C1431FWO
Istituto Medico Rio Cuarto
Río Cuarto, X5800AEV
About this study
Official title: A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Palonosetron, Ondansetron, Placebo to Ondansetron, Placebo to Palonosetron
- Keywords
- Prevention of Postoperative Nausea and Vomiting, Palonosetron, Ondansetron, Pediatric
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
OndansetronDrug
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 OndansetronDrug
Placebo to PalonosetronDrug
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron and placebo to Ondansetron | Experimental | Intervention: Drug: Palonosetron Receives: Drug: Palonosetron; Drug: Placebo to Ondansetron |
| Ondansetron and placebo to Palonosetron | Active comparator | Intervention: Drug: Comparator: Ondansetron Receives: Drug: Ondansetron; Drug: Placebo to Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Complete Response
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.
Measured: 0-24 hours after T0
Secondary outcomes (4)
Proportion of Patients With no Vomiting
Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Measured: 0-24 hours after T0
Proportion of Patients Without Emetic Episodes
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.
Measured: 0-24 hours after T0
Proportion of Patients Without Antiemetic Rescue Medication
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.
Measured: 0-24 hours after T0
Proportion of Patients Without Nausea (Patient Aged > 6 Years)
Measured: 0-24 hours after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionApr 2012
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
- 670 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
- NCT01395901
- Sponsor's protocol ID
- PALO-10-14
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2011
- Last updated
- 30 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT01395901
- Acronym / sponsor ID
- PALO-10-14
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Prevention of Postoperative Nausea and Vomiting, Palonosetron, Ondansetron, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 30 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.
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 |
|---|---|---|
| Palonosetron and placebo to Ondansetron | Experimental | Drug: Palonosetron, Drug: Placebo to OndansetronIntervention: Drug: Palonosetron |
| Ondansetron and placebo to Palonosetron | Active comparator | Drug: Ondansetron, Drug: Placebo to PalonosetronIntervention: Drug: Comparator: Ondansetron |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Male or female patient aged from full term neonate to less than 17 years.
- In-patient or out-patient scheduled to undergo one of the following procedures:
- Patient is scheduled to undergo surgery requiring general intravenous anesthesia
- Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia
- Patient weighs at least 3.2 kg
Key exclusion criteria (12 listed)
- Lactating females
- Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
- Patient having participated in any previous trial with palonosetron.
- History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
- Patient to undergo emergency surgery
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 |
|---|---|---|
| PalonosetronSingle dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) | Drug | Palonosetron and placebo to Ondansetron |
| OndansetronSingle 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 | Drug | Ondansetron and placebo to Palonosetron |
| Placebo to Ondansetron | Drug | Palonosetron and placebo to Ondansetron |
| Placebo to Palonosetron | Drug | Ondansetron and placebo to Palonosetron |
Primary outcome
Proportion of Patients With Complete Response
Time frame: 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.
4 secondary outcomes
Proportion of Patients With no Vomiting
Time frame: 0-24 hours after T0
Proportion of Patients Without Emetic Episodes
Time frame: 0-24 hours after T0
Proportion of Patients Without Antiemetic Rescue Medication
Time frame: 0-24 hours after T0
Proportion of Patients Without Nausea (Patient Aged > 6 Years)
Time frame: 0-24 hours after T0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
- 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.
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palonosetron and Ondansetron in people with Postoperative Nausea and Vomiting, run by Helsinn Healthcare SA at 44 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Ukraine, Czechia, Hungary, Poland and 3 more countries. 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 30 Jul 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 Complete Response (time frame: 0-24 hours after T0). 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 30 Jul 2014.