Nausea and VomitingPhase 3NCT06282211
the Efficacy and Safety of Ondansetron Oral Soluble Pellicles
A Phase 3 study testing Ondansetron Oral Soluble Pellicles in people with Nausea and Vomiting, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- Ondansetron Oral Soluble Pellicles
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 29 Dec 2024
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, gender is not limited;
- Histologically or cytologically confirmed diagnosis of malignant solid tumor;
- Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2; anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and
- Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy;
- Expected survival ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) physical status score ≤2;
- Patients were able to read, understand, and complete study questionnaires;
- Patients understood the study procedures and signed a written informed consent form
Who cannot join
- Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week;
- Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within one week of enrollment;
- Symptoms such as vomiting prior to randomization;
- Patients on opioid therapy (except stable dose administration);
- Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent);
- Patients who have received, or are expected to receive, radiotherapy to the abdomen (including the diaphragmatic plane and below) or pelvis within 1 week before randomization or one week after enrollment;
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- Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy;
- The patient has participated in another clinical trial within the past 4 weeks;
- Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study;
- Pregnant or lactating females;
- Presence of allergic conditions or prior serious adverse reactions to the study drug and excipients;
- Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Keya Zhi
Weihui, None Selected, 453100
Yana Zhang, 15093230340, Drzhangyana@hotmail.com
About this study
Official title: A Multicenter, Open-label, Randomized Controlled Clinical Study of the Efficacy and Safety of Ondansetron Oral Soluble Pellicles for the Prevention of Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.
Read the detailed description
The aim of this study is to observe the efficacy and safety of ondansetron in delayed nausea and vomiting by its continuous dosing, and it is planned to enroll 184 first-time recipients of highly emetogenic single-day chemotherapy regimens (cisplatin dose 60-75 mg/m2; anthracycline compounds adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ) who were initiated on a triple combination regimen of fosaprepitant + ondansetron orally soluble film + dexamethasone triple regimen for nausea and vomiting prophylaxis in patients. The primary observation was the incidence and severity of delayed nausea and vomiting in both groups from day 5 after chemotherapy to the second cycle of chemotherapy. The secondary observation indexes include the incidence and severity of delayed nausea in patients in both groups from day 5 after chemotherapy to before the second cycle of chemotherapy; the incidence and severity of anticipatory nausea/vomiting in the second cycle of chemotherapy in both groups; the incidence and severity of nausea/vomiting in patients in both groups on days 1-4 after chemotherapy; and the incidence of adverse events and serious adverse reactions, with a focus on the antiemetic drugs common constipation, headache and other events. This trial was randomized into groups, and the experimental group was preset as group A and the control group as group B. The prevention of nausea and vomiting was carried out with the triple regimen of fosaprepitant (Tanneng, Jiangsu Hausen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone prior to chemotherapy, and the patients were divided into the treatment group A and the control group B by the use of Ondansetron Oral Soluble Pellicles for continuation of the prophylaxis on the 5-7 days after the chemotherapy.
- Conditions
- Nausea and Vomiting
- Being tested
- Ondansetron Oral Soluble Pellicles
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron Oral Soluble PelliclesDrug
Also called Aiqisu
patients applying cisplatin-based chemotherapy regimen were treated with the triple combination of fosaprepitant (Tanneng, Jiangsu Haosen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone for the prophylaxis of nausea and vomiting prior to the chemotherapy, and were divided into the experimental group and the control group by whether or not to continue the prophylaxis with o Ondansetron Oral Soluble Pellicles for 5-7 days after the chemotherapy as shown in the figure below.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron Oral Soluble Pellicles | Experimental | nausea and vomiting prophylaxis with Ondansetron Oral Soluble Pellicles, 8 mg tid for 5-7 days after chemotherapy Receives: Drug: Ondansetron Oral Soluble Pellicles |
| no antiemetic drugs or drugs with antiemetic active ingredients | Sham comparator | no antiemetic drugs or drugs with antiemetic active ingredients for 5-7 days after chemotherapy Receives: Drug: Ondansetron Oral Soluble Pellicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups
The incidence of delayed vomiting was recorded and the severity of delayed vomiting was assessed by the VAS scale.
Measured: 21 days
Secondary outcomes (2)
Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups
The incidence of delayed nauseating was recorded and the severity of delayed nauseating was assessed by the VAS scale.
Measured: 21 days
Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups
The incidence of delayed nausea/vomiting was recorded and the severity of delayed nausea/vomiting was assessed by the VAS scale.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282211
- Sponsor's protocol ID
- CHASE 005
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Controlled Clinical Study of the Efficacy and Safety of Ondansetron Oral Soluble Pellicles for the Prevention of Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT06282211
- Acronym / sponsor ID
- CHASE 005
- Conditions
- Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 28 Feb 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.
The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.
Detailed description
The aim of this study is to observe the efficacy and safety of ondansetron in delayed nausea and vomiting by its continuous dosing, and it is planned to enroll 184 first-time recipients of highly emetogenic single-day chemotherapy regimens (cisplatin dose 60-75 mg/m2; anthracycline compounds adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ) who were initiated on a triple combination regimen of fosaprepitant + ondansetron orally soluble film + dexamethasone triple regimen for nausea and vomiting prophylaxis in patients. The primary observation was the incidence and severity of delayed nausea and vomiting in both groups from day 5 after chemotherapy to the second cycle of chemotherapy. The secondary observation indexes include the incidence and severity of delayed nausea in patients in both groups from day 5 after chemotherapy to before the second cycle of chemotherapy; the incidence and severity of anticipatory nausea/vomiting in the second cycle of chemotherapy in both groups; the incidence and severity of nausea/vomiting in patients in both groups on days 1-4 after chemotherapy; and the incidence of adverse events and serious adverse reactions, with a focus on the antiemetic drugs common constipation, headache and other events. This trial was randomized into groups, and the experimental group was preset as group A and the control group as group B. The prevention of nausea and vomiting was carried out with the triple regimen of fosaprepitant (Tanneng, Jiangsu Hausen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone prior to chemotherapy, and the patients were divided into the treatment group A and the control group B by the use of Ondansetron Oral Soluble Pellicles for continuation of the prophylaxis on the 5-7 days after the chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Oral Soluble Pellicles | Experimental | Drug: Ondansetron Oral Soluble Pelliclesnausea and vomiting prophylaxis with Ondansetron Oral Soluble Pellicles, 8 mg tid for 5-7 days after chemotherapy |
| no antiemetic drugs or drugs with antiemetic active ingredients | Sham comparator | Drug: Ondansetron Oral Soluble Pelliclesno antiemetic drugs or drugs with antiemetic active ingredients for 5-7 days after chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, gender is not limited;
- Histologically or cytologically confirmed diagnosis of malignant solid tumor;
- Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2; anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and
- Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy;
- Expected survival ≥ 3 months;
Key exclusion criteria (12 listed)
- Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week;
- Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within one week of enrollment;
- Symptoms such as vomiting prior to randomization;
- Patients on opioid therapy (except stable dose administration);
- Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent);
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 Soluble PelliclesAlso: Aiqisupatients applying cisplatin-based chemotherapy regimen were treated with the triple combination of fosaprepitant (Tanneng, Jiangsu Haosen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone for the prophylaxis of nausea and vomiting prior to the chemotherapy, and were divided into the experimental group and the control group by whether or not to continue the prophylaxis with o Ondansetron Oral Soluble Pellicles for 5-7 days after the chemotherapy as shown in the figure below. | Drug | Ondansetron Oral Soluble Pellicles, no antiemetic drugs or drugs with antiemetic active ingredients |
Primary outcome
Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups
Time frame: 21 days
The incidence of delayed vomiting was recorded and the severity of delayed vomiting was assessed by the VAS scale.
2 secondary outcomes
Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups
Time frame: 21 days
Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron Oral Soluble Pellicles in people with Nausea and Vomiting, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinghua Ji (13663030446, 54234317@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups (time frame: 21 days). 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 28 Feb 2024.