PalonosetronNCT03148704
Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)
An observational study of Palonosetron, run by Cttq at 1 site in China.
Trial summary
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palonosetron
- What is being tested?
- palonosetron hydrochloride capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2017to 8 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)
Who may be able to join
- 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.
Who cannot join
- All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 81st Hostital of PLA
Nanjing, Jiangsu, 210000
qin shukui
About this study
Official title: Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules
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.
- 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:
- 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]
- Conditions
- Palonosetron
- Being tested
- palonosetron hydrochloride capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetron hydrochloride capsulesDrug
Also called Ruo Shan®
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 .
| Study group | Role | What they receive |
|---|---|---|
| palonosetron palonosetron hydrochloride | A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®) Receives: Drug: palonosetron hydrochloride capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Secondary outcomes (3)
Report the efficacy of palonosetron hydrochloride capsules.
Report the control condition of nausea and vomiting.
Measured: 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.
Measured: 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 .
Measured: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start8 Mar 2017
- Primary completion8 Mar 2018 (estimated)
- Study completion8 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalonosetronStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cttq
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- qin shu kui, Study chair, The 81st Hostital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148704
- Sponsor's protocol ID
- Ruo Shan new drug monitoring
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules
- ClinicalTrials.gov ID
- NCT03148704
- Acronym / sponsor ID
- Ruo Shan new drug monitoring
- Conditions
- Palonosetron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- CttqIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 8 Mar 2018 (estimated)
- Study completion
- 8 Jun 2018 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
Detailed description
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palonosetron palonosetron hydrochloride | – | Drug: palonosetron hydrochloride capsulesA continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palonosetron hydrochloride capsulesAlso: Ruo Shan®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 . | Drug | palonosetron palonosetron hydrochloride |
Primary outcome
Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.
Time frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
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.
3 secondary outcomes
Report the efficacy of palonosetron hydrochloride capsules.
Time frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Report the widely used population characteristics.
Time frame: 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.
Time frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
Fosrolapitant and Palonosetron for Highly Emetogenic ADC-Induced Nausea and Vomiting in Solid Tumors
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A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
qin shu kui study chair
The 81st Hostital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palonosetron, run by Cttq at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zheng bo (18136659876, jtuu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using. (time frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.