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
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