Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)

Palonosetron Clinical Trial

Official title:

Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148704
• Other study ID #: Ruo Shan new drug monitoring
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2017
• Last updated: May 8, 2017
• Start date: March 8, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: May 2017
• Source: Cttq
• Contact: zheng bo
• Phone: 18136659876
• Email: jtuu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.

Description:

Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.

1. Observe the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known, and whether there is any new adverse effects.Observe the incidence and the situation of adverse effects. Pay attention to the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction. Observe other safety issues related to drug using method, drug packaging method and drug quality.

[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day]

Secondary Outcome Measures:

2. Furtherly clarify the efficacy of palonosetron hydrochloride capsules, and the widely used population characteristics, and clinical using features of palonosetron hydrochloride capsules.

[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .

• Elderly patients do not need to adjust the dosage of the drug.

• Children using the drug and dose adjustment need to be evaluated by the doctor.

• Pregnant and lactating patients using the drug need to be evaluated by the doctor.

• 5-HT3RA allergic patients do not recommend the use of this drug.

Exclusion Criteria:

• All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .

Related Conditions & MeSH terms

• Palonosetron

Intervention

Drug:
• palonosetron hydrochloride capsules
Collect all the patients' safty and efficacy data as long as they use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .

Locations

Country	Name	City	State
China	The 81st Hostital of PLA	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Cttq

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.	Report the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known; Report if there is any new adverse effects; Report the incidence and the situation of the above adverse effects; Report the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction; Report other safety issues related to drug using method, drug packaging method and drug quality.	A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Secondary	Report the efficacy of palonosetron hydrochloride capsules.	Report the control condition of nausea and vomiting.	A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Secondary	Report the widely used population characteristics.	Report the patients' disease, age, treatment, and chemotherapy drugs.	A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Secondary	Report the clinical using features of palonosetron hydrochloride capsules.	Report the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs .	A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day