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Clinical Trials in China / NCT05690802
Recruiting Not applicable

The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV

NCT05690802 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Not applicable
Started
2022-05-16
Last updated
2023-01-19

Condition(s) studied

Nausea and Vomiting

Investigational drug(s) / intervention(s)

Palonosetron hydrochloride capsules

Palonosetron hydrochloride capsules: This protocol only stipulates "Palonosetron capsule containing hydrochloric acid protocol", and does not make uniform provisions on the treatment course, and does not interfere with the actual clinical usage and dosage.

Study summary

To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * For patients with malignant tumors who can accept chemotherapy, the disease type is not limited. The specific chemotherapy scheme is the chemotherapy scheme with moderate risk of vomiting (for the risk level of vomiting, refer to the 2019 CSCO anti-tumor treatment related nausea and vomiting prevention and treatment guidelines); * 18-75 years old, KPS score ≥ 70, and the expected survival time is more than 3 months; * Before treatment, ECG, blood routine test, liver and kidney functions and electrolytes were basically normal; * All patients signed the informed consent form Exclusion Criteria: * Patients with chemotherapy contraindications, patients allergic to 5-HT3RA, pregnant women and lactating women; * People with digestive tract obstruction; Patients with serious heart disease, liver and kidney disease and metabolic disorder; Patients suffering from epilepsy or using psychotropic and sedative drugs; * Used antiemetic drugs or chemicals within 24 hours.Those who have vomited before treatment may have brain metastasis, intracranial hypertension, gastrointestinal obstruction, psychological abnormalities, etc.Patients with factors causing nausea and vomiting.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, the Air Force Medical University Xi'an Shaan'xi Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05690802 on ClinicalTrials.gov ↗ ← All trials in China