Adverse Reaction to DrugNCT02520570
Post-market Safety Reassessment of Ulinastatin for Injection
An observational study of Adverse Reaction to Drug, run by Techpool Bio-Pharma Co., Ltd. at 1 site in China.
Trial summary
1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Reaction to Drug
- What is being tested?
- ulinastatin
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Aug 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: patients with ulinastatin treated
Who may be able to join
- Patients with ulinastatin treated
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510115
Hua Lin, 86-020-81887233
About this study
- Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
- Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.
- Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.
Read the detailed description
In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.
- Conditions
- Adverse Reaction to Drug
- Being tested
- ulinastatin
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Also called UTI, urinary trypsin inhibitor, bikunin
We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.
| Study group | Role | What they receive |
|---|---|---|
| general department | Patients using ulinastatin in department beyond ICU would be labelled as general department group. Receives: Drug: ulinastatin | |
| ICU | Patients using ulinastatin in ICU would be labelled as ICU group. Receives: Drug: ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: participants will be followed for the duration of using ulinastatin, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to DrugStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for ADR Monitoring of Guangdong
- Responsible party
- Sponsor
- Investigators
- Jin Li, doctor, Principal investigator, Center for Adverse Drug Reaction Monitoring of Guangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520570
- Sponsor's protocol ID
- 002/20140709
- Status last verified
- Apr 2018
- First submitted
- 30 Jul 2015
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Safety Reassessment of Ulinastatin for Injection
- ClinicalTrials.gov ID
- NCT02520570
- Acronym / sponsor ID
- 002/20140709
- Conditions
- Adverse Reaction to Drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Center for ADR Monitoring of Guangdong
- Study start
- Aug 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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.
- Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
- Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.
- Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.
Detailed description
In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general department | – | Drug: ulinastatinPatients using ulinastatin in department beyond ICU would be labelled as general department group. |
| ICU | – | Drug: ulinastatinPatients using ulinastatin in ICU would be labelled as ICU group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with ulinastatin treated
Key inclusion criteria (1 listed)
- Patients with ulinastatin treated
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| ulinastatinAlso: UTI, urinary trypsin inhibitor, bikuninWe wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin. | Drug | ICU, general department |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: participants will be followed for the duration of using ulinastatin, an expected average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jin Li, doctor principal investigator
Center for Adverse Drug Reaction Monitoring of Guangdong
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 Adverse Reaction to Drug, run by Techpool Bio-Pharma Co., Ltd. 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 1 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 23 Apr 2018. 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 mingjuan Hua, Master (+86 020 38972288, huamj@techpool.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: participants will be followed for the duration of using ulinastatin, an expected average of 7 days). 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 23 Apr 2018.