CClinicalTrials.gg
Status unknownNCT03148704Updated May 11, 2017

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

An observational study in Palonosetron, sponsored by Cttq. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2017-05-11.

Sponsored by Cttq · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study summary

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

Read the 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]

02

Conditions studied

  • Palonosetron
03

In context

Lead sponsor

Cttq is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • palonosetron palonosetron hydrochloride

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

    Drug: palonosetron hydrochloride capsules

Interventions

  • Drugpalonosetron 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 .

    Also known as: Ruo Shan®

06

What researchers measure

Primary outcomes

  1. Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.

    1. Report the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known; 2. Report if there is any new adverse effects; 3. Report the incidence and the situation of the above adverse effects; 4. Report the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction; 5. Report 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 outcomes

  1. Report the efficacy of palonosetron hydrochloride capsules.

    Report the control condition of nausea and vomiting.

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

  2. Report the widely used population characteristics.

    Report the patients' disease, age, treatment, and chemotherapy drugs.

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

  3. Report the clinical using features of palonosetron hydrochloride capsules.

    Report the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs .

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

07

Study locations

1 of 1 sites recruiting
  • The 81st Hostital of PLA
    Nanjing, Jiangsu 210000, China
    • qin shukui · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03148704
Lead sponsor
Cttq
Responsible party
Sponsor
First posted
May 11, 2017
Start date
Mar 8, 2017
Primary completion
Mar 8, 2018 (estimated)
Completion
Jun 8, 2018 (estimated)
Last update
May 11, 2017

Study contacts

zheng bo
Contact
jtuu@163.com
18136659876
qin shu kui
study chair · The 81st Hostital of PLA

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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