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

Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules

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

Study Overview

• Status: Unknown
• Conditions: Palonosetron
• Intervention / Treatment: Drug: palonosetron hydrochloride capsules

Detailed 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]

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: zheng bo; Phone Number: 18136659876; Email: jtuu@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The 81st Hostital of PLA
      • Contact: qin shukui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)

Description

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®) .

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
palonosetron palonosetron hydrochloride; A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)	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 .; Other Names: Ruo Shan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cttq
• Investigators: Study Chair: qin shu kui, The 81st Hostital of PLA

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Anticipated): March 8, 2018
• Study Completion (Anticipated): June 8, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: Ruo Shan new drug monitoring

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No