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Palonosetron HCl Buccal Film 0.5 mg for Nausea and Vomiting
Study Summary
This trial is testing whether a long-acting anti-nausea drug is as effective when delivered by a buccal film compared to an IV injection.
- Nausea and Vomiting
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have taken any medication that helps prevent nausea and vomiting within the last day before treatment and during the study.You have a seizure disorder that requires medication to control seizures.You are currently experiencing frequent vomiting that is caused by a medical condition.You have a known reason why you cannot take medications called 5-HT3 antagonists or dexamethasone.You have been diagnosed with cancer, either for the first time and have not received chemotherapy before, or you have received chemotherapy before and have a confirmed diagnosis of cancer.You have a history of feeling very sick or throwing up after receiving chemotherapy.You are able to perform daily activities with at least half of your usual energy and ability.
- Group 1: Palonosetron HCl Buccal Film
- Group 2: Palonosetron IV Injection
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are medical personnel still enrolling individuals in this research project?
"Yes, the information available on clinicaltrials.gov supports that this trial is currently looking for patients. The trial was originally posted on March 1st, 2022 and was last updated on August 25th, 2022. There are 9 trial sites that are recruiting a total of 328 participants."
Are there any significant dangers associated with Palonosetron HCl Buccal Film 0.5 mg?
"There is existing data from Phase 3 trials that support the efficacy and safety of Palonosetron HCl Buccal Film 0.5 mg, so it received a score of 3."
In how many locations is this clinical trial being administered?
"This clinical trial is currently running at 9 sites. The sites are based in Lakeland, Massillon and Miami Lakes as well as other cities 9 other locations. It is important to select the location nearest you to minimize travel demands if you participate."
How many people are signing up to take part in this clinical trial?
"In order to begin this study, the research team needs to recruit 328 individuals that meet the necessary requirements. These patients can reside near either Watson Clinic in Lakeland, Florida or Tri-County Hematology & Oncology Associates in Massillon, Ohio."
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