To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic ChemotherapyOndansetronNCT06371014
Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy
A study testing Ondansetron oral membrane in people with To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy, run by Shanghai Children's Medical Center.
Trial summary
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy
- What is being tested?
- Ondansetron oral membrane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
- Receive moderate and low grade emetic chemotherapy;
- Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
- The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.
Who cannot join
- Children allergic to 5HT3 antagonists;
- Active infection;
- Abnormal bone marrow function (absolute neutrophil count <1000/mm3 platelet count <100000/mm3);
- Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
- Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
- vomiting 24 hours before chemotherapy begins;
- Start systemic corticosteroid therapy within 72 hours prior to study drug use, or plan to receive corticosteroids as part of a chemotherapy regimen;
- Patients with benzodiazepines or opioids
About this study
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy
- Being tested
- Ondansetron oral membrane
- Keywords
- Ondansetron mouth soluble film, Ondansetron tablet, effectiveness, security, CINV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron oral membraneDrug
A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron mouth soluble film | Experimental | Drug: ondansetron plus dexamethasone Ondansetron oral membrane lysis group, oral administration 30 minutes before chemotherapy, 8 mg bid for children over 12 years old, 4mg/ time for children 4-11 years old, bid; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy Receives: Drug: Ondansetron oral membrane |
| Ondansetron tablet | Experimental | Ondansetron tablet group, oral administration 30 minutes before chemotherapy, 5mg/m2 q12h po; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy Receives: Drug: Ondansetron oral membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rates in the Acute Phases
Complete Remission Rates in the Acute Phases
Measured: up to 6 months
Secondary outcomes (1)
Complete Remission Rates in the Delayed Phases
Complete Remission Rates in the Delayed Phases
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic ChemotherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371014
- Sponsor's protocol ID
- Ondansetron mouth soluble film
- Acronym
- Ondansetron
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roila F, Feyer P, Maranzano E, Olver I, Clark-Snow R, Warr D, Molassiotis A. Antiemetics in children receiving chemotherapy. Support Care Cancer. 2005 Feb;13(2):129-31. doi: 10.1007/s00520-004-0702-6. Epub 2004 Nov 5.
PubMed 15538642Natale JJ. Overview of the prevention and management of CINV. Am J Manag Care. 2018 Oct;24(18 Suppl):S391-S397.
PubMed 30328690Benson AB, Venook AP, Al-Hawary MM, Arain MA, Chen YJ, Ciombor KK, Cohen S, Cooper HS, Deming D, Farkas L, Garrido-Laguna I, Grem JL, Gunn A, Hecht JR, Hoffe S, Hubbard J, Hunt S, Johung KL, Kirilcuk N, Krishnamurthi S, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Nurkin S, Overman MJ, Parikh A, Patel H, Pedersen K, Saltz L, Schneider C, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Gurski LA. Colon Cancer, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Mar 2;19(3):329-359. doi: 10.6004/jnccn.2021.0012.
PubMed 33724754Patel P, Robinson PD, Thackray J, Flank J, Holdsworth MT, Gibson P, Orsey A, Portwine C, Freedman J, Madden JR, Phillips R, Sung L, Dupuis LL. Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: A focused update. Pediatr Blood Cancer. 2017 Oct;64(10). doi: 10.1002/pbc.26542. Epub 2017 Apr 28.
PubMed 28453189
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy
- ClinicalTrials.gov ID
- NCT06371014
- Acronym / sponsor ID
- Ondansetron / Ondansetron mouth soluble film
- Keywords
- Ondansetron mouth soluble film, Ondansetron tablet, effectiveness, security, CINV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron mouth soluble film | Experimental | Drug: Ondansetron oral membraneDrug: ondansetron plus dexamethasone Ondansetron oral membrane lysis group, oral administration 30 minutes before chemotherapy, 8 mg bid for children over 12 years old, 4mg/ time for children 4-11 years old, bid; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy |
| Ondansetron tablet | Experimental | Drug: Ondansetron oral membraneOndansetron tablet group, oral administration 30 minutes before chemotherapy, 5mg/m2 q12h po; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
- Receive moderate and low grade emetic chemotherapy;
- Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
- The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.
Key exclusion criteria (8 listed)
- Children allergic to 5HT3 antagonists;
- Active infection;
- Abnormal bone marrow function (absolute neutrophil count <1000/mm3 platelet count <100000/mm3);
- Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
- Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
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 |
|---|---|---|
| Ondansetron oral membraneA new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy | Drug | Ondansetron mouth soluble film, Ondansetron tablet |
Primary outcome
Complete Remission Rates in the Acute Phases
Time frame: up to 6 months
Complete Remission Rates in the Acute Phases
1 secondary outcome
Complete Remission Rates in the Delayed Phases
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 15538642Roila F, Feyer P, Maranzano E, Olver I, Clark-Snow R, Warr D, Molassiotis A. Antiemetics in children receiving chemotherapy. Support Care Cancer. 2005 Feb;13(2):129-31. doi: 10.1007/s00520-004-0702-6. Epub 2004 Nov 5.
- Background: PubMed 30328690Natale JJ. Overview of the prevention and management of CINV. Am J Manag Care. 2018 Oct;24(18 Suppl):S391-S397.
- Background: PubMed 33724754Benson AB, Venook AP, Al-Hawary MM, Arain MA, Chen YJ, Ciombor KK, Cohen S, Cooper HS, Deming D, Farkas L, Garrido-Laguna I, Grem JL, Gunn A, Hecht JR, Hoffe S, Hubbard J, Hunt S, Johung KL, Kirilcuk N, Krishnamurthi S, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Nurkin S, Overman MJ, Parikh A, Patel H, Pedersen K, Saltz L, Schneider C, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Gurski LA. Colon Cancer, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Mar 2;19(3):329-359. doi: 10.6004/jnccn.2021.0012.
- Background: PubMed 28453189Patel P, Robinson PD, Thackray J, Flank J, Holdsworth MT, Gibson P, Orsey A, Portwine C, Freedman J, Madden JR, Phillips R, Sung L, Dupuis LL. Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: A focused update. Pediatr Blood Cancer. 2017 Oct;64(10). doi: 10.1002/pbc.26542. Epub 2017 Apr 28.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron oral membrane in people with To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy, run by Shanghai Children's Medical Center.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Complete Remission Rates in the Acute Phases (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371014, which also lists 4 linked publications.
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 17 Apr 2024.