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Ondansetron · 1 trial · 2 indications
The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication.
| Arm | Type | Description |
|---|---|---|
| Secondary prophylaxis | EXPERIMENTAL | Patients already experiencing mild nausea/vomiting within 24 hours before radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment. |
| Primary prophylaxis | EXPERIMENTAL | Patients experiencing no nausea and vomiting 24 hours before commencement of radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment. |
| Name | Type | Description |
|---|---|---|
| Ondansetron | DRUG | Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment. |
Inclusion Criteria: * Informed consent * Patient will receive palliative radiation therapy considered emetogenic for bone metastases. * Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet * Group 2: Nausea and vomiting re...
Ondansetron is a small molecule being developed for nausea, specifically studied for the prophylaxis and rescue of radiation induced nausea and vomiting. It is an investigational drug in Phase 2 clinical development, and it is not approved for this use.
Ondansetron is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 2 clinical development for nausea.
Ondansetron is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its use in radiation induced nausea and vomiting.
Ondansetron has one completed Phase 2 clinical trial, identified as NCT02006056, titled 'Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting.' The trial enrolled 30 participants in Canada and was a controlled study without randomization or blinding.
The clinical trial for Ondansetron, NCT02006056, is titled 'Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting,' indicating that Ondissolve is a name associated with the drug in this study. The trial evaluated the drug for nausea and vomiting.