Flurbiprofen AxetilNCT04128410
A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
An observational study of Flurbiprofen Axetil and Cerebrospinal Fluid, run by Yi Feng, MD at 1 site in China.
Trial summary
The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Flurbiprofen Axetil, Cerebrospinal Fluid, Anesthesia, Spinal
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to Oct 2019
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I or lII, both sexes, aged 18-85 yr
Who may be able to join
- Patients undergoing lower extremity surgery under spinal or combined spinal-epidural anesthesia will be selected.
Who cannot join
- asthma, liver insufficiency, renal insufficiency, peptic ulcer, allergy to NSAIDs, and a history use of NSAIDs within two weeks before operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yi Feng, MD, 08601088325590, yifeng65@sina.com
About this study
The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients.
Read the detailed description
The patients undergoing spinal anesthesia for lower extremity surgery will be studied. Flurbiprofen axetil 100mg will be injected intravenously. CSF 1ml and blood 2ml will be obtained simultaneously every 5 minutes after intravenous injection in 50 min( T1~T10).CSF and blood samples will be used to detected S-flurbiprofen and R-flurbiprofen concentrations by using Liquid Chromatography-Mass Spectrometry. And the CSF/blood S-flurbiprofen and R-flurbiprofen concentrations ratio were calculated.
- Conditions
- Flurbiprofen Axetil, Cerebrospinal Fluid, Anesthesia, Spinal, Aged
- Keywords
- S-flurbiprofen, R-flurbiprofen, cerebrospinal fluid, aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T1 | At 5 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T2 | At 10 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T3 | At 15 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T4 | At 20 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T5 | At 25 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T6 | At 30 minutes after flurbiprofen axetil injected intravenously, 14 patients' samples were required to be collected,including 7 younger patients | |
| T7 | At 35 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T8 | At 40 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T9 | At 45 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected | |
| T10 | At 50 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients.
The samples will be used to be determined plasma and CSF drug concentrations.
Measured: perioperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flurbiprofen AxetilStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Feng, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128410
- Sponsor's protocol ID
- 2019PHB169-01
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 16 Oct 2019
- 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 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
- ClinicalTrials.gov ID
- NCT04128410
- Acronym / sponsor ID
- 2019PHB169-01
- Conditions
- Flurbiprofen Axetil, Cerebrospinal Fluid, Anesthesia, Spinal, Aged
- Keywords
- S-flurbiprofen, R-flurbiprofen, cerebrospinal fluid, aged
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Yi Feng, MDUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 16 Oct 2019 (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.
The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients.
Detailed description
The patients undergoing spinal anesthesia for lower extremity surgery will be studied. Flurbiprofen axetil 100mg will be injected intravenously. CSF 1ml and blood 2ml will be obtained simultaneously every 5 minutes after intravenous injection in 50 min( T1~T10).CSF and blood samples will be used to detected S-flurbiprofen and R-flurbiprofen concentrations by using Liquid Chromatography-Mass Spectrometry. And the CSF/blood S-flurbiprofen and R-flurbiprofen concentrations ratio were calculated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| T1 | – | –At 5 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T2 | – | –At 10 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T3 | – | –At 15 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T4 | – | –At 20 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T5 | – | –At 25 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T6 | – | –At 30 minutes after flurbiprofen axetil injected intravenously, 14 patients' samples were required to be collected,including 7 younger patients |
| T7 | – | –At 35 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T8 | – | –At 40 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T9 | – | –At 45 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
| T10 | – | –At 50 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I or lII, both sexes, aged 18-85 yr
Key inclusion criteria (1 listed)
- Patients undergoing lower extremity surgery under spinal or combined spinal-epidural anesthesia will be selected.
Key exclusion criteria (1 listed)
- asthma, liver insufficiency, renal insufficiency, peptic ulcer, allergy to NSAIDs, and a history use of NSAIDs within two weeks before operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients.
Time frame: perioperation
The samples will be used to be determined plasma and CSF drug concentrations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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.
Yi Feng, MD study chair
Peking University People's Hospital
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 Flurbiprofen Axetil and Cerebrospinal Fluid, run by Yi Feng, MD 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 16 Oct 2019. 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 Yi Feng, MD (08601088325590, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients. (time frame: perioperation). 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 16 Oct 2019.