the Efficacy and Safety of Ondansetron Oral Soluble Pellicles (NCT06282211) | Clinical Trial Compass
UnknownPhase 3
the Efficacy and Safety of Ondansetron Oral Soluble Pellicles
China184 participantsStarted 2024-02-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years, gender is not limited;
✓. Histologically or cytologically confirmed diagnosis of malignant solid tumor;
✓. 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
Exclusion criteria
✕. 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);
What they're measuring
1
Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups
Timeframe: 21 days
Trial details
NCT IDNCT06282211
SponsorThe First Affiliated Hospital of Xinxiang Medical College
✕. 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;
✕. 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;